Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Piper Medical Products · 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) |
|---|---|---|---|---|---|
| K993558 | EZFLOW MAX, MODEL 1007 | Piper Medical Products | 1999-11-12 | 23 | 0 |
| K990384 | EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 | Piper Medical Products | 1999-04-26 | 77 | 0 |
| K982408 | AEROTEE, MODEL # 1001 | Piper Medical Products | 1998-09-14 | 66 | 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