Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Path Medical GmbH — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
197 daysmedian FDA review time
257 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220139 | QScreen | Path Medical GmbH | 2022-08-03 | 197 | 0 |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, S | Path Medical GmbH | 2022-06-22 | 257 | 4 |
| K211147 | ALGO 7i | Path Medical GmbH | 2021-10-14 | 178 | 0 |
| K133012 | SENTIERO | Path Medical GmbH | 2014-06-09 | 257 | 4 |
| K131141 | EARPROBE | Path Medical GmbH | 2013-06-27 | 65 | 0 |
| K100661 | EARPROBE | Path Medical GmbH | 2010-07-01 | 115 | 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