Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FFL — Predicate Candidate Screening
52 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
166 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190492 | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | 2019-07-18 | 140 | 0 |
| K172299 | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | 2017-09-19 | 50 | 0 |
| K102887 | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC38145 | Percutaneous Systems, Inc. | 2011-05-16 | 228 | 0 |
| K082803 | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 | Percutaneous Systems, Inc. | 2008-11-13 | 50 | 0 |
| K052048 | ACCORDION | Percutaneous Systems, Incorporated | 2005-09-13 | 46 | 0 |
| K012581 | REPROCESSED STONE RETRIEVAL BASKETS | Sterilmed, Inc. | 2002-02-14 | 189 | 1 |
| K972091 | AMS FOREIGN BODY EXTRATOR | American Medical Systems, Inc. | 1997-08-29 | 86 | 0 |
| K970489 | COMEG ENDOSCOPY GRASPING FORCEPS | Comeg Endoscopy | 1997-03-19 | 37 | 0 |
| K962387 | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) | Olympus America, Inc. | 1996-07-31 | 41 | 0 |
| K961248 | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TOR | C.R. Bard, Inc. | 1996-05-28 | 57 | 0 |
| K955049 | OLYMPUS FG-45/46-1 GRASPING FORCEPS | Olympus America, Inc. | 1995-12-15 | 39 | 0 |
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | Annex Medical, Inc. | 1995-10-26 | 37 | 0 |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1995-07-19 | 107 | 0 |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1995-05-11 | 24 | 0 |
| K935737 | STONE EXTRACTOR, GRASPING FORCEPS | Boston Scientific Corp | 1994-09-07 | 280 | 0 |
| K935721 | STONE EXTRACTOR | Boston Scientific Corp | 1994-08-22 | 265 | 0 |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | Annex Medical, Inc. | 1994-02-25 | 151 | 0 |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | Surgitek | 1994-01-11 | 189 | 0 |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1994-01-07 | 101 | 0 |
| K930349 | STONE RETRIEVAL BASKET | Endomedix | 1993-06-09 | 135 | 0 |
| K924027 | DISLODGER, STONE, BASKET, URETERAL, METAL | Annex Medical, Inc. | 1992-10-20 | 70 | 0 |
| K922678 | LOOP RETRIEVER | Annex Medical, Inc. | 1992-08-25 | 82 | 0 |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Intramed Laboratories, Inc. | 1992-08-03 | 90 | 0 |
| K921233 | BARD 4-WIRE URETEROSCOPIC STONE | C.R. Bard, Inc. | 1992-04-27 | 45 | 0 |
| K914505 | STONE BASKET | Surgitek Medical Engineering Corp. | 1991-12-09 | 61 | 0 |
| K910603 | LOOP RETRIEVER | Annex Medical, Inc. | 1991-03-11 | 27 | 0 |
| K900269 | PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE | Porges Corp. | 1990-07-03 | 166 | 0 |
| K896992 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1990-02-08 | 59 | 0 |
| K896169 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1989-12-18 | 54 | 0 |
| K891254 | UROLOGICAL STONE BASKET | Northgate Research, Inc. | 1989-03-22 | 14 | 0 |
| K884738 | CANDELA STONE BASKETS | Candela Laser Corp. | 1989-02-09 | 87 | 0 |
| K871777 | VAN-TEC REUSABLE HELICAL STONE BASKET | Van-Tec, Inc. | 1987-06-17 | 42 | 0 |
| K871779 | HELICAL STONE BASKET (DISPOSABLE) | Van-Tec, Inc. | 1987-06-17 | 42 | 0 |
| K870696 | VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH | Van-Tec, Inc. | 1987-03-30 | 39 | 0 |
| K870615 | VAN-TEC POSITIVE OPEN SEGURA BASKET | Van-Tec, Inc. | 1987-03-25 | 41 | 0 |
| K864874 | SEGURA DRETLER BASKET | Van-Tec, Inc. | 1987-03-10 | 88 | 0 |
| K862729 | PENN 3-RING HANDLE | Penn Medical Devices, Inc. | 1986-10-24 | 98 | 0 |
| K863081 | 4-WIRE (CARSON) STONE EXTRACTOR | Cook Urological, Inc. | 1986-10-24 | 73 | 0 |
| K861469 | DUTHOY STONE BASKET | Lake Region Mfg., Inc. | 1986-05-15 | 23 | 0 |
| K860268 | VAN-TEC DEFLECTING GRASPING FORCEPS | Van-Tec, Inc. | 1986-04-03 | 66 | 0 |
| K860946 | DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER | Van-Tec, Inc. | 1986-04-03 | 22 | 0 |
| K860269 | VAN-TEC DEFLECTING LOOP RETRIEVER | Van-Tec, Inc. | 1986-03-25 | 57 | 0 |
| K860270 | VAN-TEC DEFLECTING ROTATING SEGURA BASKET | Van-Tec, Inc. | 1986-03-25 | 57 | 0 |
| K854652 | ANGIOMED URETERAL STONE DISLODGERS | Angiomed U.S., Inc. | 1986-02-10 | 83 | 0 |
| K851922 | URETERAL STONE DISLODGER | Inter-Med Corp. | 1985-08-02 | 92 | 0 |
| K851965 | WILSON-COOK STONE EXTRACTOR | Wilson-Cook Medical, Inc. | 1985-07-29 | 87 | 0 |
| K850954 | URETERAL DILATOR & URETERAL STONE DISLODGER | American Edwards Laboratories | 1985-04-03 | 26 | 0 |
| K841942 | SEGURA BASKET | Van-Tec, Inc. | 1984-07-19 | 69 | 0 |
| K831875 | BALLOON DILATION HELICAL STONE EXTRACT | Vpi | 1983-09-12 | 91 | 0 |
| K811580 | GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET | Porges Catheter Corp. | 1981-06-26 | 21 | 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