Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Percussionaire Corp. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
277 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905234 | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES | Percussionaire Corp. | 1991-06-13 | 218 | 1 |
| K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS | Percussionaire Corp. | 1991-05-03 | 177 | 3 |
| K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES | Percussionaire Corp. | 1991-04-18 | 162 | 1 |
| K900315 | PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN | Percussionaire Corp. | 1990-10-26 | 277 | 0 |
| K900313 | PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN | Percussionaire Corp. | 1990-10-26 | 277 | 0 |
| K900314 | PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN | Percussionaire Corp. | 1990-10-26 | 277 | 0 |
| K896586 | RATE INCREASE FOR IPPB/IPV | Percussionaire Corp. | 1990-01-09 | 48 | 0 |
| K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS | Percussionaire Corp. | 1989-10-30 | 49 | 0 |
| K892886 | PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR | Percussionaire Corp. | 1989-10-27 | 191 | 0 |
| K895486 | BIRD (VDR) SINUSOIDAL PERCUSSIONATORS | Percussionaire Corp. | 1989-10-13 | 32 | 0 |
| K884832 | PERCUSSIONAIRE RESPIRATORS (MULTIPLE) | Percussionaire Corp. | 1989-09-14 | 300 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda