Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
First Medical Devices Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
77 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903657 | MODEL 610 MODIFIED | First Medical Devices Corp. | 1990-09-04 | 26 | 0 |
| K895185 | FIRST MEDIC MODEL 610P | First Medical Devices Corp. | 1989-10-27 | 77 | 0 |
| K883584 | FIRST MEDIC MODE 610 | First Medical Devices Corp. | 1988-10-06 | 45 | 0 |
| K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | First Medical Devices Corp. | 1988-05-12 | 76 | 0 |
| K871136 | HEARTSTART 2000, MANUAL DEFIBRILLATOR | First Medical Devices Corp. | 1987-05-12 | 53 | 0 |
| K871135 | HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE | First Medical Devices Corp. | 1987-05-12 | 53 | 0 |
| K860676 | HEARTSTART 2000 | First Medical Devices Corp. | 1986-04-30 | 64 | 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