510(k) Report

FDA applicant

Ventec Life Systems, Inc.

Bothell, WA1 decision2017–201716 recalls

FDA records 1 decision for Ventec Life Systems, Inc. (Bothell, WA) in 2017: 1 510(k) clearance. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 5 predicates, 0 of them its own earlier devices. 16 recalls are linked to its devices, 14 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Ventec Life Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

13in 2026

2021: 12024: 1, 1 Class I2025: 1, 1 Class I2026 (partial year): 13, 12 Class I
2017high 13 (2026) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Ventec Life Systems, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ventec Life Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 20171cites it

What has FDA decided for it lately?

  • K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 201714 Class I recalls

The one decision as Ventec Life Systems, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K162877V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number…Sep 17, 2026Class I
  • K162877VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.Sep 17, 2026Class I
  • K162877VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for…Sep 17, 2026Class I
  • K162877VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory…Sep 17, 2026Class I
  • K162877VC (Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory…Sep 17, 2026Class I
  • K162877VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for…Sep 17, 2026Class I