Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ODB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
103 daysmedian FDA review time
326 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183171 | ScopeSeal Duodenoscope Protective Device | Gi Scientific, LLC | 2019-10-08 | 326 | 0 |
| K153698 | LumenR Tissue Retractor System | Lumenr, LLC | 2016-04-19 | 118 | 0 |
| K080550 | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 | Minos Medical | 2008-06-10 | 103 | 0 |
| K060475 | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL | Olympus Medical Systems Corporation | 2006-03-17 | 22 | 0 |
| K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS | Karl Storz Endoskop GmbH | 1994-09-14 | 47 | 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