Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DRI · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | Datex Division Instrumentarium Corp. | 1990-07-06 | 31 | 0 |
| K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | Datex Division Instrumentarium Corp. | 1990-07-06 | 31 | 0 |
| K822316 | HEART MONITOR BRACELET ALARM | Hmba | 1982-09-21 | 49 | 0 |
| K802326 | PRESSURE MONITORING LINES | Stanco Medical, Inc. | 1980-10-10 | 17 | 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