Newport
e36O VENTILATOR, E MODEL CHINESE NA POWER
8manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
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 | Covidien LP, United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| 510(k) | K111146 |
| Record published | 2015-10-22 |
| Record revised | 2025-06-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment humidity 0 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 95 % RH; Storage environment temperature -20 to 60 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2020-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E360E-CN-NA | In distribution | |
| SEN3420A | In distribution | |
| DLE360T-US-NA | In distribution | |
| DLHT50-H1-B | In distribution | |
| DLE360S-US-NA | Withdrawn | |
| E360P-SY-NA | Withdrawn |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 |
|---|---|
| K151252 | 2016-03-29 |
Recalls Naming This Product
9 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 | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2025-05-21 | Class I | Component design/selection | Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert | 4842 | |
| Newport Medical Instruments, Inc. | 510(k) number | 2017-03-30 | Class I | Software in the Use Environment | Medtronic is issuing a voluntary field corrective action for all its Newport” HT70 and Newport” HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm. | 12,966 | 2020-07-18 |
| Newport Medical Instruments, Inc. | 510(k) number | 2013-04-05 | Class I | Component design/selection | Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to in | 2528 ventilators and 1864 power pac batteries | 2015-03-10 |
| Newport Medical Instruments, Inc. | 510(k) number | 2012-08-03 | Class I | Nonconforming Material/Component | May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. | 72 | 2014-04-14 |
| Flight Medical Innovations Ltd. | 510(k) number | 2011-08-10 | Not classified | Device Design | The recall was initiated because Flight Medical Innovations Ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off. | 363 total units, all in the US | 2012-05-21 |
| Newport Medical Instruments, Inc. | 510(k) number | 2010-05-14 | Not classified | Other | The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for | 1,113 EP cases | 2011-06-01 |
| Newport Medical Instruments, Inc. | 510(k) number | 2009-01-13 | Not classified | Other | The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plug | 2011-06-01 | |
| Newport Medical Instruments, Inc. | 510(k) number | 2007-07-31 | Not classified | Other | Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not l | 8,160 | 2012-03-21 |
| Newport Medical Instruments, Inc. | 510(k) number | 2005-10-29 | Not classified | Other | Lack of alarm prior to shutdown. | 3654 | 2012-08-02 |
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.