510(k) Report

FDA applicant

Ventus Medical, Inc.

Belmont, CA5 decisions2008–20122 recalls

FDA records 5 decisions for Ventus Medical, Inc. (Belmont, CA) from 2008 to 2012: 5 510(k) clearances. Most are in product codes OHP (Expiratory Resistance Valve, Intranasal, For…) and LWF (Dilator, Nasal). Its devices cite 16 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided Ventus Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2008: 22009: 12010: 12012: 1
2008high 2 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2009: 12012: 1
2008high 1 (2009) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Ventus Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea3decisions
  • LWFDilator, Nasal1decision
  • MNRVentilatory Effort Recorder1decision

Whose devices does it build on?

Its devices cite 16 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 20083cite it
  • K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50)Ventus Medical, Inc. · 20102cite it
  • K120665Invent Snoring DeviceVentus Medical, Inc. · 20121cites it
  • K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 20091cites it

What has FDA decided for it lately?

  • K120665Invent Snoring DeviceVentus Medical, Inc. · 2012
  • K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50)Ventus Medical, Inc. · 2010
  • K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 20091 recall
  • K080983Provent Nasal CannulaVentus Medical, Inc. · 20081 recall
  • K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008

All 5 as Ventus Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K090398Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single…Feb 3, 2012
  • K080983The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended…Dec 3, 2009