Vocsn
The FDA filing describes VOCSN as a mechanical ventilator combined with additional conventional respiratory therapies. Its described therapies include ventilation, oxygen concentration and…
The FDA filing describes VOCSN as a mechanical ventilator combined with additional conventional respiratory therapies.
Its described therapies include ventilation, oxygen concentration and delivery, cough assist, and suction. The indications cover pediatric through adult patients weighing at least 5 kg.
Listed Item
V+O+C+S+N, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com
Device Description and Stated Use
The filing states that the system may provide continuous or intermittent ventilatory support in invasive or noninvasive applications and may be used in home, hospital, institutional, or transport settings, including portable applications.
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 | Ventec Life Systems, 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 |
| 510(k) | K162877 |
| Record published | 2021-02-23 |
| Record revised | 2025-12-10 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 70 °C; Storage environment humidity 0 to 90 % RH; Storage environment atmospheric pressure 50 to 110 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V+C, Japanese | In distribution | |
| V+O+C+S+N, Japanese | In distribution | |
| V+C, English | In distribution | |
| V+O+C+S+N, English | In distribution |
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 |
|---|---|
| K162877 | 2017-04-07 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|
| Ventec Life Systems, Inc. | 510(k) number | 2026-05-08 | Class II | Vendor change control | Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and abs | 1 |
| Ventec Life Systems, Inc. | 510(k) number | 2026-03-25 | Class I | Process change control | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to r | 42 |
| Ventec Life Systems, Inc. | 510(k) number | 2025-02-03 | Class I | Component change control | Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less i | 30 |
| Ventec Life Systems, Inc. | 510(k) number | 2024-01-09 | Class I | Process control | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breat | 250 breathing circuits |
| Ventec Life Systems, Inc. | 510(k) number | 2021-05-10 | Class II | Device Design | Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy. | 1,934 devices (415 device that have not been updated) |
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.