Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Healthcare Supply Co., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
228 daysmedian FDA review time
259 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925214 | SHAVE PREP TRAYS (NON-STERILE) | American Healthcare Supply Co., Inc. | 1993-07-02 | 259 | 0 |
| K925216 | STERILE SKIN SCRUB TRAYS | American Healthcare Supply Co., Inc. | 1993-06-22 | 249 | 0 |
| K925215 | STERILE SURGICAL INSTRUMENT TRAYS | American Healthcare Supply Co., Inc. | 1993-06-01 | 228 | 0 |
| K924834 | PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) | American Healthcare Supply Co., Inc. | 1993-03-23 | 179 | 0 |
| K924835 | VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 | American Healthcare Supply Co., Inc. | 1993-03-23 | 179 | 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