Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sentinelle Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
286 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103274 | SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING | Sentinelle Medical, Inc. | 2011-08-18 | 286 | 0 |
| K100113 | VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARR | Sentinelle Medical, Inc. | 2010-04-22 | 98 | 0 |
| K093672 | AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION | Sentinelle Medical, Inc. | 2009-12-11 | 14 | 0 |
| K070244 | AEGIS | Sentinelle Medical, Inc. | 2007-02-09 | 15 | 0 |
| K060873 | VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL CO | Sentinelle Medical, Inc. | 2006-04-14 | 15 | 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