Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ODD — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
260 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/ | Olympus Medical Systems Corp. | 2025-05-27 | 90 | 0 |
| K202583 | BioShield biopsy valve EUS - Linear | STERIS Corporation | 2020-11-06 | 59 | 0 |
| K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and | Wilson-Cook Medical, Inc. | 2018-03-20 | 260 | 0 |
| K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | United States Endoscopy Group, Inc. | 2007-03-19 | 27 | 1 |
| K011149 | DISPOSABLE BENDING CANNULA PR-233Q | The Olympus Optical Co. | 2001-05-15 | 29 | 0 |
| K010993 | ALIEN RX MICRO CANNULA, MODEL 4530 | Boston Scientific Corp | 2001-04-30 | 27 | 0 |
| K973205 | WILSON-COOK STRICTURE MEASURING CATHETER | Wilson-Cook Medical, Inc. | 1997-11-24 | 90 | 0 |
| K963051 | ERCP CANNULA | United States Endoscopy Group, Inc. | 1997-03-28 | 234 | 0 |
| K953967 | ENDOSCOPIC CATHETER | Act Medical, Inc. | 1996-01-22 | 153 | 0 |
| K950700 | BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAP | C.R. Bard, Inc. | 1995-04-27 | 71 | 0 |
| K950729 | OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) | Olympus America, Inc. | 1995-03-17 | 29 | 0 |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Surgitek Medical Engineering Corp. | 1991-06-25 | 123 | 0 |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Primrose Medical, Inc. | 1989-09-08 | 304 | 0 |
| K845018 | DAVOL ERCP CANNULA | C.R. Bard, Inc. | 1985-01-15 | 20 | 0 |
| K834414 | ERCP CANNULA | Hobbs Medical, Inc. | 1984-02-04 | 51 | 0 |
| K833417 | ENDOSCOPIC RETROGRADE | Microvasive | 1983-11-28 | 56 | 0 |
| K820431 | E.R.C.P. CANNULAS | American Endoscopy, Inc. | 1982-04-09 | 51 | 0 |
| K802443 | E.R.C.P. CANNULA PRODUCT | Mill-Rose Laboratory | 1980-10-23 | 16 | 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