510(k) Report

FDA applicant

Bird Products Corp.

Palm Spring, CA35 decisions1980–200422 recalls

FDA records 35 decisions for Bird Products Corp. (Palm Spring, CA) from 1980 to 2004: 35 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). Its devices cite 28 predicates, 15 of them its own earlier devices. 22 recalls are linked to its devices, 13 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 Bird Products Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bird Products Corp. since 2007.

Recalls per year

12in 2016

2007: 62011: 12013: 1, 1 Class I2016: 12, 12 Class I
2007high 12 (2016) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Bird Products Corp.’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?

  • CBKVentilator, Continuous, Facility Use21decisions
  • BZRMixer, Breathing Gases, Anesthesia Inhalation5decisions
  • BZDVentilator, Non-Continuous (Respirator)3decisions
  • BZKSpirometer, Monitoring (W/Wo Alarm)1decision
  • BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1decision
  • BYLTent, Oxygen1decision

Also: BTI (1), CBC (1), CAP (1).

Whose devices does it build on?

Its devices cite 28 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 times; 15 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.

  • K032451Bird Tbird Vela VentilatorBird Products Corp. · 20047cite it
  • K013642AVEABird Products Corp. · 20025cite it
  • K950484Tbird VS Ventilator and Tbird Avs VentilatorBird Products Corp. · 19965cite it
  • K973646Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 19983cite it
  • K911962Bird Sentry Air/Oxygen MicroblenderBird Products Corp. · 19913cite it
  • K022674Bird Avea VentilatorBird Products Corp. · 20023cite it

What has FDA decided for it lately?

  • K032451Bird Tbird Vela VentilatorBird Products Corp. · 20041 recall
  • K022674Bird Avea VentilatorBird Products Corp. · 20025 recalls
  • K013642AVEABird Products Corp. · 200213 Class I recalls
  • K020730Orion Nasal Cpap SystemBird Products Corp. · 2002
  • K020746Bird Tbird Vela VentilatorBird Products Corp. · 2002
  • K003770Bird Tbird Legacy VentilatorBird Products Corp. · 2000
  • K990856Heritage Nasal Cpap System, Model P/N 15682Bird Products Corp. · 2000
  • K993449Bird V.I.P. Gold/SterlingBird Products Corp. · 19992 recalls

All 35 as Bird Products Corp. →

What has been recalled?

22 recalls linked to its devices; the latest:

  • K103211AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended…May 17, 2016Class I
  • K103211Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended…May 17, 2016Class I
  • K103211Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically…May 17, 2016Class I
  • K103211AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control…May 17, 2016Class I
  • K103211AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator…May 17, 2016Class I
  • K103211Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to…May 17, 2016Class I

Other applicant names beginning “Bird”

FDA records each applicant name separately; these may or may not be the same firm.

Bird Life Design 7Bird & Cronin, Inc. 1