Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FBP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
312 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151191 | OES ELITE Telescopes, Protective Tube | Olympus Winter & Ibe GmbH | 2015-11-24 | 204 | 0 |
| K113062 | ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMAL | Endoservice Optical Instruments GmbH | 2012-08-21 | 312 | 0 |
| K031758 | ACMI M4 TELESCOPES | Acmi Corporation | 2003-09-02 | 88 | 0 |
| K984607 | PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PAN | Richard Wolf Medical Instruments Corp. | 1999-03-05 | 67 | 0 |
| K760177 | TELESCOPE, RIGID ENDOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 | 55 | 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