Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DTG — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
400 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092364 | MODEL 220 PATIENT MAGNET | Cyberonics, Inc. | 2009-11-03 | 90 | 0 |
| K960849 | MAGNO ALARM | Cardiac Assist Devices, Inc. | 1997-03-26 | 400 | 0 |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | Cardiac Control Systems, Inc. | 1989-09-26 | 42 | 0 |
| K831926 | IMPLANTABLE ENDOCARDIAL PACING LEADS | Oscor, Inc. | 1984-03-12 | 271 | 0 |
| K813153 | TEST MAGNET | Pacesetter Systems | 1981-12-02 | 26 | 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