Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Healthcare Corp. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
316 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924192 | I.V. START KIT (AHC-50-54954 | American Healthcare Corp. | 1993-08-27 | 372 | 0 |
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | American Healthcare Corp. | 1993-06-17 | 316 | 0 |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | American Healthcare Corp. | 1993-06-17 | 316 | 0 |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | American Healthcare Corp. | 1993-06-17 | 316 | 0 |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | American Healthcare Corp. | 1993-06-17 | 316 | 0 |
| K924193 | TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) | American Healthcare Corp. | 1993-06-16 | 300 | 0 |
| K924191 | TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL | American Healthcare Corp. | 1993-04-02 | 225 | 0 |
| K924194 | TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) | American Healthcare Corp. | 1993-01-06 | 139 | 0 |
| K924195 | TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES | American Healthcare Corp. | 1993-01-06 | 139 | 0 |
| K923834 | TRACHEOSTOMY CARE SET WITH GLOVES | American Healthcare Corp. | 1992-12-10 | 132 | 0 |
| K905135 | LAPAROTOMY SPONGES | American Healthcare Corp. | 1991-03-06 | 111 | 0 |
| K905136 | GAUZE SPONGES, INTERNAL AND EXTERNAL | American Healthcare Corp. | 1991-03-06 | 111 | 0 |
| K905178 | DELUXE SANITARY PAD | American Healthcare Corp. | 1991-03-04 | 105 | 0 |
| K863631 | SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS | American Healthcare Corp. | 1986-10-16 | 29 | 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