510(k) Report

FDA applicant

Percussionaire Corp.

Sandpoint, ID11 decisions1989–19915 recalls

FDA records 11 decisions for Percussionaire Corp. (Sandpoint, ID) from 1989 to 1991: 11 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and NHJ (Device, Positive Pressure Breathing…). 5 recalls are linked to its devices, 4 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 Percussionaire Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Percussionaire Corp. since 2007.

Recalls per year

2in 2024

2020: 12023: 2, 2 Class I2024: 2, 2 Class I
2007high 2 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Percussionaire 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 Use8decisions
  • NHJDevice, Positive Pressure Breathing, Intermittent2decisions
  • DZDTube, Orthodontic1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K895485Bird (Ipv) Noncontinuous VentilatorsPercussionaire Corp. · 19893cite it

What has FDA decided for it lately?

  • K905234TXP Transporter Family and Related AccessoriesPercussionaire Corp. · 19911 Class I recall
  • K905235VDR Sinusoidal Percusionator Family/Relate AccessPercussionaire Corp. · 19912 Class I recalls
  • K905236Ipv Percussionator Family & Related AccessoriesPercussionaire Corp. · 19911 Class I recall
  • K900313Percussionaire (R) VDR-3 Imv Percus/Respir 1250 MinPercussionaire Corp. · 1990
  • K900315Percussionaire TXP Transporter/Respirators 750 MinPercussionaire Corp. · 1990
  • K900314Percussionaire (R) Oscillatron-1 Percuss 1300 MinPercussionaire Corp. · 1990
  • K896586Rate Increase for Ippb/IpvPercussionaire Corp. · 1990
  • K895485Bird (Ipv) Noncontinuous VentilatorsPercussionaire Corp. · 1989

All 11 as Percussionaire Corp. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K905235VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D…Dec 23, 2024Class I
  • K905236Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary…Sep 16, 2024Class I
  • K905234High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123Dec 12, 2023Class I
  • K905235Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or…Mar 28, 2023Class I
  • K905235Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.Sep 14, 2020Class II