Ventec Life Systems, Inc.

Bothell, WA, US

VENTEC LIFE SYSTEMS, INC. appears in FDA device records in Bothell, WA. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 5
Registered establishments: 2

510(k) clearance history

FDA records hold 1 510(k) clearance for Ventec Life Systems, Inc. in 2017.

Clearances by year, as a table

510(k) clearance decisions for Ventec Life Systems, Inc., by decision year
Year	Clearances
2017	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K162877	VOCSN Unified Respiratory System	CBK	Substantially Equivalent	2017-04-07

Registered establishments

FDA registered establishments for Ventec Life Systems, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3013095415	3013095415	VENTEC LIFE SYSTEMS, INC.	22002 26th Ave SE, Bothell, WA 98021 US	2026	BTA BTT BZE CAH CAT CAW CBK NHJ NOU
3017520736	3017520736	VENTEC LIFE SYSTEMS, INC.	12350 NE Woodinville Drive, Woodinville, WA 98072 US	2026	BTA BZE CAH CAW CBK NHJ NOU

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2525-2026	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.	Class II	2026-05-08	Open, Classified
Z-1942-2026	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-enriched environment may increase fire risk	Class I	2026-03-25	Open, Classified
Z-1196-2025	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.	Class I	2025-02-03	Open, Classified
Z-1070-2024	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 support for the care of individuals who require mechanical ventilation.	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 patients.	Class I	2024-01-09	Open, Classified
Z-1902-2021	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/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;	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.	Class II	2021-05-10	Open, Classified

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain