Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
North American Medical Products, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
219 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001965 | SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS | North American Medical Products, Inc. | 2001-02-02 | 219 | 0 |
| K905305 | SAFE-SITE NEEDLE COVER | North American Medical Products, Inc. | 1991-02-12 | 76 | 0 |
| K895948 | PORT-O-SCOPE(TM) | North American Medical Products, Inc. | 1990-03-27 | 168 | 0 |
| K896072 | D.L. SCOPE OPHTHALMOSCOPE | North American Medical Products, Inc. | 1989-11-27 | 39 | 0 |
| K862661 | D.L. SCOPE(R) OTOSCOPE | North American Medical Products, Inc. | 1986-08-08 | 25 | 0 |
| K841778 | D.L. SCOPE BLADE & HANDLE | North American Medical Products, Inc. | 1984-05-23 | 23 | 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