Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcraft Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
6 daysmedian FDA review time
277 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860467 | ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 | Medcraft Corp. | 1986-11-10 | 277 | 0 |
| K791795 | COMP-ACT IV | Medcraft Corp. | 1979-09-27 | 13 | 0 |
| K760510 | MONITORING SYSTEM, REHABILITATION | Medcraft Corp. | 1976-08-30 | 6 | 0 |
| K760509 | TREADMILL, DIAGNOSTIC | Medcraft Corp. | 1976-08-30 | 6 | 0 |
| K760508 | ACCUTAPE 24 | Medcraft Corp. | 1976-08-30 | 6 | 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