Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medikmark, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
792 daysmedian FDA review time
796 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953474 | IV START KIT | Medikmark, Inc. | 1995-10-02 | 70 | 0 |
| K923960 | UPPER EXTERMITY DRAPE KIT | Medikmark, Inc. | 1994-10-07 | 792 | 0 |
| K921733 | TRACHEOSTOMY CARE TRAY | Medikmark, Inc. | 1994-06-15 | 796 | 0 |
| K921730 | C-SECTION PACK | Medikmark, Inc. | 1994-06-15 | 796 | 0 |
| K921732 | MINOR LAP SET | Medikmark, Inc. | 1994-06-15 | 796 | 0 |
| K920341 | LACERATION TRAYS | Medikmark, Inc. | 1992-04-23 | 90 | 0 |
| K920339 | DRESSING CHANGE TRAY | Medikmark, Inc. | 1992-04-23 | 90 | 0 |
| K920340 | SUTURE REMOVAL KIT | Medikmark, Inc. | 1992-04-23 | 90 | 3 |
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