Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med General — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
106 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K791097 | CEPTORTRODE WITH CEPTOR HESIVE | Med General | 1979-08-03 | 52 | 0 |
| K791098 | SINGLE-USE MINI-BULLDOG | Med General | 1979-06-22 | 10 | 0 |
| K790763 | MAXI-VAC TM | Med General | 1979-04-23 | 5 | 0 |
| K790269 | CEPTOR HESIVE | Med General | 1979-02-26 | 21 | 0 |
| K782006 | MEDGENERAL SINGLE-USE BULLDOG | Med General | 1978-12-15 | 14 | 0 |
| K781239 | MYO-STIM | Med General | 1978-11-03 | 106 | 0 |
| K780632 | MAXICEPTOR | Med General | 1978-08-14 | 119 | 0 |
| K780698 | STIMULATORS, NERVE, ELECTRICAL | Med General | 1978-05-12 | 16 | 0 |
| K780117 | CARDIOMETER | Med General | 1978-02-03 | 11 | 0 |
| K771702 | VESSEL-STABILIZER | Med General | 1977-12-13 | 96 | 0 |
| K771701 | VESSEL-CLUDE | Med General | 1977-12-13 | 96 | 0 |
| K771765 | MYO-CHECK | Med General | 1977-09-30 | 11 | 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