Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Medical Devices, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
106 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974561 | MOISTAIR FLUID AIR TUBING SET | American Medical Devices, Inc. | 1998-02-19 | 76 | 0 |
| K971853 | ENDOVIEW SPPHIRE LENS SET | American Medical Devices, Inc. | 1997-08-06 | 78 | 0 |
| K970882 | ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA. | American Medical Devices, Inc. | 1997-06-24 | 106 | 0 |
| K970875 | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) | American Medical Devices, Inc. | 1997-05-20 | 71 | 0 |
| K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | American Medical Devices, Inc. | 1997-05-20 | 71 | 0 |
| K970878 | ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAM | American Medical Devices, Inc. | 1997-05-06 | 57 | 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