Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Medical Mfg., Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
301 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982029 | SHARPS COLLECTION CONTAINER - SAF-T-SHELL | American Medical Mfg., Inc. | 1999-04-06 | 301 | 0 |
| K961454 | AMMI MAGNI-GUARD | American Medical Mfg., Inc. | 1996-07-25 | 101 | 0 |
| K915066 | DISPOSABLE SKIN MARKER | American Medical Mfg., Inc. | 1992-05-14 | 188 | 0 |
| K915064 | DISPOSABLE CAUTERY ABRASIVE PAD | American Medical Mfg., Inc. | 1992-03-11 | 124 | 0 |
| K915065 | I.V.IRRIGATION POLE | American Medical Mfg., Inc. | 1992-02-11 | 95 | 0 |
| K915068 | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | American Medical Mfg., Inc. | 1992-02-06 | 90 | 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