510(k) Report

FDA applicant

Infrasonics Corp.

San Diego, CA20 decisions1984–19950 recalls

FDA records 20 decisions for Infrasonics Corp. (San Diego, CA) from 1984 to 1995: 20 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BZO (Set, Tubing And Support, Ventilator (W Harness)). No recall is linked to its devices.

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 Infrasonics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infrasonics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Infrasonics Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Infrasonics Corp.’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 Use10decisions
  • BZOSet, Tubing And Support, Ventilator (W Harness)2decisions
  • BZCCalculator, Pulmonary Function Data2decisions
  • BZDVentilator, Non-Continuous (Respirator)1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • BTICompressor, Air, Portable1decision

Also: CAF (1), BZR (1), CAH (1).

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K884521Star SyncInfrasonics Corp. · 19891cites it
  • K905272Adult Star, ModificationInfrasonics Corp. · 19911cites it
  • K840865Infant Star VentilatorInfrasonics Corp. · 19841cites it
  • K920954Air StarInfrasonics Corp. · 19921cites it
  • K922654Ventilator Adult Star ModificationInfrasonics Corp. · 19921cites it
  • K923704Infant Star Series 500Infrasonics Corp. · 19921cites it

What has FDA decided for it lately?

  • K943106Adult VentilatorInfrasonics Corp. · 1995
  • K952878Oxy/Star Low Flow BlenderInfrasonics Corp. · 1995
  • K934753Star Breathing CircuitsInfrasonics Corp. · 1993
  • K922654Ventilator Adult Star ModificationInfrasonics Corp. · 1992
  • K923704Infant Star Series 500Infrasonics Corp. · 1992
  • K922477Model 105 Ventilator, ModificationInfrasonics Corp. · 1992
  • K920954Air StarInfrasonics Corp. · 1992
  • K911804Infrasonics Ventilator Adult Star, ModificationInfrasonics Corp. · 1992

All 20 as Infrasonics Corp. →