Percussionaire Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Percussionaire Corp.” (first 1989, latest 1991), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 191 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 8 | 8 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 2 | 2 |
| DZD | Tube, Orthodontic | 1 | 1 |
Review panels
- Anesthesiology (10)
- Dental (1)
Most recent Percussionaire Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905234 | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES | CBK | 1991-06-13 | 218 |
| K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS | CBK | 1991-05-03 | 177 |
| K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES | NHJ | 1991-04-18 | 162 |
| K900315 | PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN | CBK | 1990-10-26 | 277 |
| K900314 | PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN | CBK | 1990-10-26 | 277 |
| K900313 | PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN | CBK | 1990-10-26 | 277 |
| K896586 | RATE INCREASE FOR IPPB/IPV | DZD | 1990-01-09 | 48 |
| K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS | NHJ | 1989-10-30 | 49 |
| K892886 | PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR | CBK | 1989-10-27 | 191 |
| K895486 | BIRD (VDR) SINUSOIDAL PERCUSSIONATORS | CBK | 1989-10-13 | 32 |
1 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 7 recall events; 7 initiated in the last five years. Most recent: 2025-09-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Percussionaire Corp.?
FDA lists 11 510(k) clearances under the applicant name “Percussionaire Corp.” (first 1989, latest 1991), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Percussionaire Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Percussionaire Corp. is 191 days.
Which FDA product codes appear under Percussionaire Corp.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 8); NHJ (Device, Positive Pressure Breathing, Intermittent, 2); DZD (Tube, Orthodontic, 1).
Next steps
- See all 11 Percussionaire Corp. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Percussionaire Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.