510(k) Report

510(k) · Cleared

Cleared

Bird 1000 PV Portable Ventilator

K925422510(k) TraditionalCleared May 13, 1993198-day reviewClass II21 CFR 880.6740

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bird Products Corp. · CBC Bottle, Collection And Trap, Breathing System (Uncalibrated)

Cleared on May 13, 1993 after a 198-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 13, 1993
Review
198 days
Class
Class II
Product code
CBC
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K925422Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CBC devices

CBC Bottle, Collection And Trap, Breathing System (Uncalibrated): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBC

FDA has decided no CBC device since 2007.

Median 510(k) review, days · CBC

Too few CBC 510(k)s in any year since 2007 to give a median.

Recalls per year · CBC

No recall names CBC since 2007.

Adverse event reports per year · CBC

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2025

MAUDE reports naming product code CBC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Bird Products Corp.

35 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in CBC

The CBC category page

  • K790035Ambu Suction BoosterNarco Air-Shields · 1979
  • K760082Bottle, Condensate (#1628)Inspiron Corp. · 1976

https://510kreport.com/device/K925422 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925422: Bird 1000 PV Portable Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925422

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026