Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Np Medical, Inc. — 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) |
|---|---|---|---|---|---|
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Conn | Np Medical, Inc. | 2023-04-19 | 442 | 0 |
| K203265 | nPro Surgical Mask | Np Medical, Inc. | 2021-02-09 | 96 | 0 |
| K130023 | K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR | Np Medical, Inc. | 2013-04-03 | 90 | 0 |
| K973916 | NP MEDICAL CAPLESS LUER ACTIVATED VALVE | Np Medical, Inc. | 1998-03-09 | 146 | 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