Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NQG · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070036 | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING | Ascent Healthcare Solutions | 2007-08-17 | 226 | 0 |
| K070034 | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DE | Ascent Healthcare Solutions | 2007-08-17 | 226 | 0 |
| K063844 | REPROCESSED HEART STABILIZERS AND POSITIONERS | Sterilmed, Inc. | 2007-03-15 | 79 | 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