Performatrak
PerformaTrak Mask with Standard Elbow, Leak1, 4 Point Headgear, Single Use, China, Small
8manufacturers in China registered for this device type
35catalogue numbers in this listing
14510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-05-12 |
| Record revised | 2024-10-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH |
| Packaging | Multipack of 10 |
| Distribution end date | 2021-02-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PerformaTrak Mask with SE, Large, Reusable Pack, INTL | In distribution | |
| PERFORMATRAK FULL SE W CAPSTRAP, INT, SMALL | In distribution | |
| PERFORMATRAK FULL SE W CAPSTRAP, LARGE | In distribution | |
| PerformaTrak Full Mask, Medium, w/SE and CapStrap, SU | In distribution | |
| PerformaTrak Full Mask, Small, w/SE w/CapStrap, SU | In distribution | |
| Standard Elbow Starter Kit, PerformaTrak plus CapStrap | In distribution | |
| PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM | In distribution | |
| PerformaTrak Full Mask, Large, w/SE and CapStrap, SU | In distribution | |
| Performatrak Mask w/SE and Headgr, Large, Disp, INTL | In distribution | |
| PerformaTrak SE Basic Kit, USA | In distribution | |
| Standard Elbow Starter Kit, Oro-Nasal Package | In distribution | |
| Performatrak Mask with SE and Headgr, Small, Disp, INTL | In distribution | |
| Performatrak plus Performax Basic Kit, Domestic | In distribution | |
| PerformaTrak Mask SE, Medium, Reusable Pack, International | In distribution | |
| PerformaTrak Mask with SE, Small, Reusable Pack, INTL | In distribution | |
| PERFORMATRAK FULL SE W CAPSTRAP, INT, MEDIUM | In distribution | |
| Performatrak Mask w/SE and Headgr, Med, Disp, INTL | In distribution | |
| PerformaTrak SE Mask w/Headgear, Disp, Small, USA | In distribution | |
| PERFORMATRAK FULL SE W CAPSTRAP, INT, LARGE | In distribution | |
| PerformaTrak SE Mask w/Headgear, Disp, Medium, USA | In distribution | |
| PerformaTrak SE Basic Kit, International | In distribution | |
| PERFORMATRAK FULL SE W CAPSTRAP, SMALL | In distribution | |
| PerformaTrak SE Mask w/Headgear, Disp, Large, USA | In distribution | |
| PerformaTrak SE Mask w 4 PT Headgear, SU, Medium, CN | Withdrawn | |
| PerformaTrak SE Leak1 4PT Headgear, Small, Single Use, China | Withdrawn | |
| PERFORMATRAK FULL SE W CAPSTRAP, JP, LARGE | Withdrawn | |
| PERFORMATRAK FULL SE W CAPSTRAP, JP, MEDIUM | Withdrawn | |
| PERFORMATRAK SE REUSABLE PACK, MEDIUM, KOREA | Withdrawn | |
| PERFORMATRAK FULL SE W CAPSTRAP, JPN, SMALL | Withdrawn | |
| Performatrak SE Mask w/Headgear, Disp, MEDIUM, KR | Withdrawn | |
| PERFORMATRAK SE REUSABLE PACK, LARGE, KOREA | Withdrawn | |
| PerformaTrak SE Mask w 4 Point Headgear, SU, Large, CN | Withdrawn | |
| Performatrak SE Mask w/Headgear, Disp, LARGE, KR | Withdrawn | |
| PERFORMATRAK SE REUSABLE PACK, SMALL, KOREA | Withdrawn | |
| Performatrak SE Mask w/Headgear, Disp, SMALL, KR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
| Vent | Zoll Medical Corporation | 32 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243394 | 2024-12-30 |
| K181166 | 2019-07-18 |
| K181170 | 2019-07-18 |
| K150638 | 2015-09-18 |
| K120639 | 2012-07-10 |
| K111610 | 2011-10-14 |
| K101129 | 2010-09-16 |
| K093905 | 2010-05-12 |
| K093416 | 2010-01-29 |
| K034040 | 2004-01-21 |
| K023135 | 2003-01-03 |
| K001208 | 2000-05-12 |
| K981072 | 1998-11-12 |
| K921726 | 1992-04-23 |
Recalls
37 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-03-02 | Class I | Software design | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | 113,717 units | |
| 2026-03-02 | Class I | Under Investigation by firm | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | 113717 | |
| 2026-03-02 | Class I | Under Investigation by firm | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | 113,717 units | |
| 2026-03-02 | Class I | Software design | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | 113,717 units | |
| 2026-03-02 | Class I | Under Investigation by firm | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | 113,717 units | |
| 2026-03-02 | Class I | Under Investigation by firm | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | 113,717 units | |
| 2026-03-02 | Class I | Software design | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | 113,717 units | |
| 2026-03-02 | Class I | Software design | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | 113,717 units | |
| 2024-10-07 | Class I | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could lead to inaccurate flow measurements. | 82,800 units | |
| 2024-10-07 | Class I | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could lead to inaccurate flow measurements. | 1,322 units | |
| 2024-10-07 | Class I | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could lead to inaccurate flow measurements. | 34,146 units | |
| 2024-10-07 | Class I | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could lead to inaccurate flow measurements. | 804 units | |
| 2024-10-07 | Class I | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could lead to inaccurate flow measurements. | 9,999 units | |
| 2024-10-07 | Class I | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could lead to inaccurate flow measurements. | 24,249 units | |
| 2024-10-07 | Class I | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could lead to inaccurate flow measurements. | 1,244 units | |
| 2024-07-16 | Class I | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | 90,910 US; 56,273 ROW | |
| 2024-03-19 | Class I | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | 775 units | |
| 2024-03-19 | Class I | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | 1,002 units | |
| 2024-03-19 | Class I | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | 789 units | |
| 2024-03-19 | Class I | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | 9,999 units | |
| 2024-03-19 | Class I | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | 76,713 units | |
| 2024-03-19 | Class I | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | 56,012 units | |
| 2024-03-19 | Class I | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. | 1,233 units | |
| 2023-11-27 | Class II | Device Design | The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harm | 100,126 (54,691 US; 45,435 OUS) in total | |
| 2023-05-25 | Class II | Under Investigation by firm | There are errors present in the Korean Instructions For Use where the word “invasive,” was incorrectly translated to “noninvasive”. | 1,581 units | |
| 2023-05-01 | Class I | Under Investigation by firm | The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients we | 22,237 devices | |
| 2023-05-01 | Class I | Under Investigation by firm | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia | 18,855 devices | |
| 2023-05-01 | Class I | Under Investigation by firm | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia | 57,395 devices | |
| 2023-05-01 | Class I | Under Investigation by firm | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia | 21,520 devices | |
| 2023-03-01 | Class I | Under Investigation by firm | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device | 62,826 total devices | |
| 2023-03-01 | Class I | Under Investigation by firm | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device | 62826 total devices | |
| 2023-03-01 | Class I | Under Investigation by firm | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device | 62826 total devices | |
| 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 20,807 | |
| 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 9 | |
| 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 537 devices | |
| 2021-12-22 | Class I | Mixed-up of materials/components | Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices | 473 devices | |
| 2021-12-22 | Class I | Mixed-up of materials/components | Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices | 205 kits | |
| 2021-07-26 | Class II | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure Increase” and the second issue is described as “Pressure Drift (Continuous Usage | 10,000 (FEMA Stockpile Only) | |
| 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 255810 | |
| 2019-11-19 | Class I | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected r | 21 | 2021-03-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.