Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pentax Medical · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
272 daysmedian FDA review time
649 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | Pentax Medical | 2019-10-21 | 60 | 0 |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | Pentax Medical | 2018-07-18 | 470 | 0 |
| K172156 | PENTAX Medical EPK-3000 Video Imaging System | Pentax Medical | 2018-04-05 | 261 | 0 |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018-02-07 | 649 | 1 |
| K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax Medical | 2017-09-20 | 272 | 0 |
| K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | Pentax Medical | 2013-04-10 | 240 | 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