Newport Medical
Perm. 15MM/Ped Circuit W/O Water Trap and Exhalation Valve
8manufacturers in China registered for this device type
6catalogue numbers in this listing
17510(k) clearances naming this product code
12recalls 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 | Newport Medical Instruments, Inc., 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 | 2018-02-01 |
| Record revised | 2022-04-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Special storage condition: ; |
| Sizes | Width 1.38 in; length 2 in |
| Distribution end date | 2025-09-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HT600051 | In distribution | ||
| KIT3420A | In distribution | ||
| FLT3209P-C | Width 1.38 in | 5 | In distribution |
| HT600051 | In distribution | ||
| PBC460A | Withdrawn | ||
| PBC335J | Withdrawn |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 |
|---|---|
| K121891 | 2012-11-09 |
| K111146 | 2011-12-01 |
| K101803 | 2010-09-08 |
| K090888 | 2009-11-18 |
| K082724 | 2008-12-16 |
| K061094 | 2006-07-28 |
| K053502 | 2006-01-10 |
| K030780 | 2004-01-23 |
| K992133 | 2000-08-04 |
| K972833 | 1999-09-23 |
| K941308 | 1995-08-25 |
| K941309 | 1995-03-06 |
| K901785 | 1990-08-10 |
| K883809 | 1989-06-23 |
| K860438 | 1986-05-06 |
| K844350 | 1984-12-27 |
| K820746 | 1982-04-16 |
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 | 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 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-09-20 | Not classified | Other | The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These | 22 units total | 2011-06-03 |
| 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 |
| 2010-04-14 | Not classified | Other | The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on Printed Circuit Board (PCB) 2104A in the Newport e360 ventilator. Ventilators manufactured between Septemb | 990 | 2011-08-18 |
| 2009-10-27 | Not classified | Mixed-up of materials/components | Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered. | 18 | 2011-06-08 |
| 2009-07-22 | Not classified | Other | The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. The Dual Pac system has | 11, 333 units total | 2011-06-01 |
| 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 | |
| 2008-12-15 | Not classified | Software design | In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced unexpected device alert alarms. Newpo | 4,117 units (214 Domestically; 3,903 Internationally) | 2011-11-04 |
| 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 |
| 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.