Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcomp Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
16 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861806 | MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT) | Medcomp Technologies, Inc. | 1986-05-23 | 14 | 0 |
| K861804 | MEDCARE SUTURE REMOVAL KIT | Medcomp Technologies, Inc. | 1986-05-23 | 14 | 0 |
| K861805 | MEDCARE FORCEPS (THUMB, TISSUE) | Medcomp Technologies, Inc. | 1986-05-23 | 14 | 0 |
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | Medcomp Technologies, Inc. | 1986-05-23 | 14 | 0 |
| K860683 | MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPS | Medcomp Technologies, Inc. | 1986-03-13 | 16 | 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