Data / Medical devices / United States / Ventec Life Systems, Inc.
Ventec Life Systems, Inc.: FDA-registered device maker in Bothell, WA, United States, 8 510(k) clearances
Ventec Life Systems, Inc. is registered with the FDA (registration 3013095415) in Bothell, WA, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 6, 2020. 7 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013095415
- Address
- 22002 26th Ave SE, Bothell, WA, United States, 98021
- Owner or operator
- REACT HEALTH (10054872)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 7, 2017
- Registered through
- 2026
- Brand names listed
- HomeFill® Oxygen System, Optiflow, Perfecto2V Oxygen Concentrator, Perfecto2 Oxygen Concentrator; Platinum® Oxygen Concentrator, Platinum® Mobile Oxygen Concentrator, Platinum® Mobile Oxygen Concentrator with Connectivity; Mobile Medical Application Accessory; USB Bluetooth Dongle, PreciseRx Pediatric Flowmeter, VOCSN
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous, Ventilator, Home Use | NOU | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2020 | K200890 | Invacare Perfecto2V Oxygen Concentrator | CAW | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| August 29, 2019 | K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity | CAW | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| April 7, 2017 | K162877 | VOCSN Unified Respiratory System | CBK | Substantially Equivalent | Ventec Life Systems, Inc. | accessdata.fda.gov |
| September 27, 2016 | K160630 | Invacare Platinum Mobile Oxygen Concentrator | CAW | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| July 7, 2003 | K020332 | RESPIRATORY HUMIDIFIER, MODEL MR850 | BTT | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. | accessdata.fda.gov |
| July 23, 2002 | K021685 | VENTURE HOMEFILL II WITH OXYGEN CONSERVER | CAW | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| July 2, 2002 | K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 | CAW | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| September 15, 1992 | K914488 | MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS | CAW | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 17, 2026 | 99835 | Class I | Ongoing | VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. | accessdata.fda.gov |
| July 28, 2026 | 99660 | Class II | Ongoing | HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve | Labeling; Oxygen Cylinders do not contain required medical gas labeling | accessdata.fda.gov |
| May 8, 2026 | 98888 | Class II | Ongoing | VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 | 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 absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition. | accessdata.fda.gov |
| March 25, 2026 | 98554 | Class I | Ongoing | VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 | 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 reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enr | accessdata.fda.gov |
| February 3, 2025 | 96136 | Class I | Ongoing | VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002 | 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 inspiratory volume, less inspiratory pressure, and less PEEP delivered. | accessdata.fda.gov |
| January 9, 2024 | 93806 | Class I | Ongoing | VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory supp | 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 breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent p | accessdata.fda.gov |
| May 10, 2021 | 87838 | Class II | Ongoing | Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/En | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Continuous, Ventilator, Home Use
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Ventilator, Continuous, Facility Use
- All makers of Device, Positive Pressure Breathing, Intermittent
- All makers of Filter, Bacterial, Breathing-Circuit
Updated October 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.