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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Wiltek Medical, Inc. — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

143 daysmedian FDA review time
143 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990231WILTEK HOT BIOPSY FORCEPSWiltek Medical, Inc.1999-04-13780
K922989WILTEK IRRIGAITON/ASPIRATION TUBE SETWiltek Medical, Inc.1994-02-156030
K930419WILTEK BIOPSY FORCEPSWiltek Medical, Inc.1993-06-011260
K914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERWiltek Medical, Inc.1992-01-07690
K914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERWiltek Medical, Inc.1992-01-07690
K914132WILTEK ELECTROCAUTERY ACTIVE CORDWiltek Medical, Inc.1991-09-25120
K914131WILTEK ELECTROCAUTERY ADAPTORWiltek Medical, Inc.1991-09-25120
K912122CHOLANGIOGRAPHY CATHETERWiltek Medical, Inc.1991-09-231320
K912288WILTEK STANDARD CHOLANGIOGRAPHY CATHETERWiltek Medical, Inc.1991-09-231230
K910334ELECTROCAUTERY PROBEWiltek Medical, Inc.1991-02-21270
K894865WILTEK BALLOON STONE EXTRACTORWiltek Medical, Inc.1989-12-211430
K894869WILTEK POLYPECTOMY SNAREWiltek Medical, Inc.1989-12-211430
K894860WILTEK GASTRIC FEEDING TUBEWiltek Medical, Inc.1989-12-211430
K894866WILTEK STONE EXTRACTORWiltek Medical, Inc.1989-12-211430
K894870WILTEK NASAL BILIARY DRAINAGE SETWiltek Medical, Inc.1989-12-211430
K894867WILTEK E.R.C.P. CATHETERWiltek Medical, Inc.1989-12-211430
K894862WILTEK GRASPING FORCEPSWiltek Medical, Inc.1989-12-211430
K894861WILTEK PAPILLOTOMEWiltek Medical, Inc.1989-12-211430
K894863WILTEK CYTOLOGY BRUSHWiltek Medical, Inc.1989-12-211430
K894871WILTEK BILIARY STENT SETWiltek Medical, Inc.1989-12-211430
K894868WILTEK VARICES INJECTION NEEDLEWiltek Medical, Inc.1989-12-211430

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