Percussionaire
Sinusoidal Bronchotron and Universal Monitron Transport, French.
8manufacturers in China registered for this device type
17catalogue numbers in this listing
8510(k) clearances naming this product code
4recalls 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 | Percussionaire Corp., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K905235 |
| Record published | 2016-05-26 |
| Record revised | 2024-03-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case, case of 5 |
| Distribution end date | 2026-07-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A50605-D | In distribution | |
| F00007-1 | In distribution | |
| F00008-1 | In distribution | |
| F00007-1 | In distribution | |
| S20020 | In distribution | |
| A50094-D | In distribution | |
| F00008-1 | In distribution | |
| A50096-D | Withdrawn | |
| A50606-TXP | Withdrawn | |
| F00038-2 | Withdrawn | |
| F00038-2FR | Withdrawn | |
| F00038-1FR | Withdrawn | |
| F00029-1 | Withdrawn | |
| F00038-1 | Withdrawn | |
| F00029-1 | Withdrawn | |
| TXP5 | Withdrawn | |
| F00008-1FR | Withdrawn |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 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K905234 | 1991-06-13 |
| K905235 | 1991-05-03 |
| K900313 | 1990-10-26 |
| K900314 | 1990-10-26 |
| K900315 | 1990-10-26 |
| K892886 | 1989-10-27 |
| K895486 | 1989-10-13 |
| K884832 | 1989-09-14 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Percussionaire Corp. | 510(k) number | 2024-12-23 | Class I | Process control | Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation. | 4,727 packs/cases |
| Percussionaire Corp. | 510(k) number | 2023-12-12 | Class I | Process control | Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user | 2145 units |
| Percussionaire Corp. | 510(k) number | 2023-03-28 | Class I | Process control | Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy. | 195 |
| Percussionaire Corp. | 510(k) number | 2020-09-14 | Class II | Device Design | Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware. | 212 |
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.