Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quinton Electrophysiology Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971570 | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | Quinton Electrophysiology Corp. | 1997-12-29 | 244 | 0 |
| K925346 | EP AMP, MODEL #901 | Quinton Electrophysiology Corp. | 1993-04-30 | 190 | 0 |
| K893836 | EPLAB (ELECTROCARDIOGRAPHIC MONITOR) | Quinton Electrophysiology Corp. | 1989-09-08 | 107 | 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