Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pneumedics, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904633 | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | 1991-03-12 | 168 | 0 |
| K894667 | MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP | Pneumedics, Inc. | 1989-10-19 | 86 | 0 |
| K863087 | SPIROLOOP-PULMONARY EXERCISE SYSTEM | Pneumedics, Inc. | 1986-10-27 | 76 | 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