Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sentec AG — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
213 daysmedian FDA review time
273 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243765 | LuMon(TM) System | Sentec AG | 2025-08-07 | 244 | 0 |
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024-05-17 | 273 | 0 |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Stays | Sentec AG | 2015-12-17 | 213 | 3 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WI | Sentec AG | 2010-12-03 | 170 | 6 |
| K071672 | SENTEC DIGITAL MONITORING SYSTEM | Sentec AG | 2007-09-12 | 85 | 1 |
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