Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Medical Technology, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
486 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963808 | CHOICE POWERED WHEELCHAIR | American Medical Technology, Inc. | 1997-02-12 | 142 | 0 |
| K905745 | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM | American Medical Technology, Inc. | 1992-04-23 | 486 | 0 |
| K874567 | RESUSCITATOR | American Medical Technology, Inc. | 1988-02-29 | 116 | 0 |
| K874430 | NEEDLE CONTAINER | American Medical Technology, Inc. | 1988-01-04 | 68 | 0 |
| K874360 | PLASTIC TUBING CONNECTOR | American Medical Technology, Inc. | 1987-11-17 | 25 | 0 |
| K873313 | SURGICAL DRAPE | American Medical Technology, Inc. | 1987-09-04 | 18 | 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