Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Devilbiss Co. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
93 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874041 | DEVILBISS MODEL 8500D | The Devilbiss Co. | 1987-12-23 | 79 | 0 |
| K872094 | VACU-AIDE | The Devilbiss Co. | 1987-10-15 | 136 | 0 |
| K872826 | ULTRA-NEB 99 ULTRASONIC NEBULIZER | The Devilbiss Co. | 1987-09-04 | 50 | 0 |
| K872470 | DEVO/MC44 OXYGEN CONCENTRATOR | The Devilbiss Co. | 1987-08-03 | 87 | 0 |
| K854520 | PULMO-AIDE MODEL 5610D | The Devilbiss Co. | 1985-12-09 | 27 | 0 |
| K852209 | DEVO/MC29 OXYGEN CONCENTRATOR MC29D | The Devilbiss Co. | 1985-06-24 | 34 | 0 |
| K851695 | ULTRA-NEB 100 ULTRASONIC NEBULIZER | The Devilbiss Co. | 1985-06-05 | 44 | 0 |
| K830174 | DE VO/44 OXYGEN CONCENTRATOR #444 | The Devilbiss Co. | 1983-02-17 | 30 | 0 |
| K801526 | SURVEYOR I, RESPIRATORY COMPUTER SYSTEM | The Devilbiss Co. | 1980-07-21 | 19 | 0 |
| K792385 | DEVO OXYGEN CONCENTRATOR, MODEL 955 | The Devilbiss Co. | 1979-12-05 | 9 | 0 |
| K781073 | PULMO-SONIC | The Devilbiss Co. | 1978-09-27 | 93 | 0 |
| K770157 | DEVILBISS OXYGEN ENRICHER | The Devilbiss Co. | 1977-02-07 | 14 | 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