Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXR · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
246 daysmedian FDA review time
413 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243566 | CardioTag™ | Cardiosense, Inc. | 2025-07-22 | 246 | 0 |
| K160656 | CorSens | Corsens Medical , Ltd. | 2016-11-21 | 258 | 0 |
| K081603 | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Heartforce Medical, Inc. | 2009-07-24 | 413 | 0 |
| K870442 | QUANTASCOPE | Vital Science Corp. | 1987-08-11 | 189 | 0 |
| K863508 | FRANTZ MEDICAL ELECTRODE | Frantz Medical Development, Ltd. | 1987-02-06 | 150 | 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