Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Manner Medical Products — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K760221 | I.P.P.B., DIS. W/MANIFOLD/NEBULIZER | Manner Medical Products | 1976-08-03 | 22 | 0 |
| K760220 | TUBING, SINGLE USE OXYGEN SUPPLY | Manner Medical Products | 1976-08-03 | 22 | 0 |
| K760218 | CANNULAE, PLASTIC DISPOSABLE NASAL | Manner Medical Products | 1976-08-03 | 22 | 0 |
| K760219 | MASKA, OXYGEN VINYL D-SP. SINGLE USE | Manner Medical Products | 1976-08-03 | 22 | 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