Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcor, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
337 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K792609 | LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. | Medcor, Inc. | 1980-11-19 | 337 | 0 |
| K802223 | QUINTREX 0515 PROGRAMMABLE PULSE GEN. | Medcor, Inc. | 1980-09-12 | 0 | 0 |
| K802224 | QUINTREX 0516 PROG. PULSE GENERATOR SYS | Medcor, Inc. | 1980-09-12 | 0 | 0 |
| K791678 | LITHICRON II 0403 IMPLANTABLE PACEMAKER | Medcor, Inc. | 1979-09-07 | 10 | 0 |
| K791095 | LITHICRON MODEL 0401, PACEMAKER | Medcor, Inc. | 1979-08-10 | 59 | 0 |
| K780430 | LITHICRON F PROGRAMMABLE PULSE GEN | Medcor, Inc. | 1978-12-22 | 280 | 0 |
| K771538 | LITHICRON MODEL 3-70C-B PULSE GENERATOR | Medcor, Inc. | 1977-08-22 | 11 | 0 |
| K770507 | PULSE GENERATOR, LITKICRON MODEL 3-70H | Medcor, Inc. | 1977-04-07 | 21 | 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