Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Van-Tec, Inc. — Predicate Candidate Screening
52 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
85 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880099 | VAN-TEC BLADDER EVACUATOR | Van-Tec, Inc. | 1988-03-02 | 50 | 1 |
| K880096 | VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP | Van-Tec, Inc. | 1988-03-02 | 50 | 0 |
| K880095 | BERGER PROSTATE CULTURE CYTOLOGY BRUSH | Van-Tec, Inc. | 1988-03-02 | 50 | 0 |
| K880098 | VAN-TEC AUTO BIOPSY NEEDLE | Van-Tec, Inc. | 1988-03-02 | 50 | 0 |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Van-Tec, Inc. | 1988-02-29 | 48 | 0 |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | Van-Tec, Inc. | 1988-02-11 | 125 | 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 |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | Van-Tec, Inc. | 1987-03-30 | 39 | 0 |
| K870557 | VAN-TEC PUMPING SYSTEM | Van-Tec, Inc. | 1987-03-30 | 48 | 0 |
| K870698 | VAN-TEC PROSTATE BIOPSY NEEDLE | Van-Tec, Inc. | 1987-03-25 | 34 | 0 |
| K865087 | VAN-TEC DOUBLE SHEATH GRASPING FORCEPS | Van-Tec, Inc. | 1987-03-25 | 85 | 0 |
| K865085 | KAMINSKY COMBINATION STENT & INJECTION CATHETER | Van-Tec, Inc. | 1987-03-25 | 85 | 0 |
| K870735 | PROSTATIC ASPIRATION BIOPSY SET | Van-Tec, Inc. | 1987-03-25 | 28 | 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 |
| K870694 | VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER | Van-Tec, Inc. | 1987-03-10 | 19 | 3 |
| K870734 | TEFLON BIOPSY CATHETER W/TIP ANGLE | Van-Tec, Inc. | 1987-03-10 | 13 | 0 |
| K870556 | VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET | Van-Tec, Inc. | 1987-03-10 | 28 | 0 |
| K870695 | VAN-TEC URETHRAL DILATATION SYSTEM | Van-Tec, Inc. | 1987-03-10 | 19 | 0 |
| K870697 | VAN-TEC ONE STEP URETERAL DILATATION CATHETER | Van-Tec, Inc. | 1987-03-10 | 19 | 0 |
| K865086 | WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE | Van-Tec, Inc. | 1987-03-10 | 70 | 0 |
| K870555 | VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET | Van-Tec, Inc. | 1987-03-10 | 28 | 0 |
| K860771 | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE | Van-Tec, Inc. | 1986-04-23 | 51 | 0 |
| K860268 | VAN-TEC DEFLECTING GRASPING FORCEPS | Van-Tec, Inc. | 1986-04-03 | 66 | 0 |
| K860267 | MARDIS DANGLER URETERAL STENT SET | Van-Tec, Inc. | 1986-04-03 | 66 | 1 |
| 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 |
| K860337 | VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. | Van-Tec, Inc. | 1986-03-25 | 55 | 0 |
| K860270 | VAN-TEC DEFLECTING ROTATING SEGURA BASKET | Van-Tec, Inc. | 1986-03-25 | 57 | 0 |
| K851160 | VAN-TEC GUIDE WIRE W/HYDROMER COATING | Van-Tec, Inc. | 1985-07-29 | 129 | 0 |
| K851158 | VAN-TEC MEATAL DILATOR | Van-Tec, Inc. | 1985-04-15 | 24 | 0 |
| K851162 | AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER | Van-Tec, Inc. | 1985-04-15 | 24 | 0 |
| K851144 | URETERAL DILATION SET | Van-Tec, Inc. | 1985-04-09 | 19 | 0 |
| K841941 | VAN-TEC OCCLUSION BALLOON CATHETER | Van-Tec, Inc. | 1984-08-08 | 89 | 0 |
| K841940 | VAN-TEC URETERAL DILATION BALLOON CATH | Van-Tec, Inc. | 1984-08-03 | 84 | 0 |
| K841942 | SEGURA BASKET | Van-Tec, Inc. | 1984-07-19 | 69 | 0 |
| K832807 | PEDIATRIC ILLUMINATING URETERAL | Van-Tec, Inc. | 1983-10-19 | 62 | 0 |
| K833242 | DEFLECTING GUIDE WIRE | Van-Tec, Inc. | 1983-10-19 | 62 | 0 |
| K832808 | URETERAL DILATION SET | Van-Tec, Inc. | 1983-10-14 | 57 | 0 |
| K830803 | URINARY DIVERSION STENT | Van-Tec, Inc. | 1983-05-05 | 52 | 0 |
| K830802 | LOOP RETRIEVER | Van-Tec, Inc. | 1983-04-28 | 45 | 0 |
| K830840 | OPEN ENDED URETERAL CATHETER | Van-Tec, Inc. | 1983-04-06 | 21 | 4 |
| K822491 | DISPOSABLE GRASPING FORCEPS | Van-Tec, Inc. | 1982-09-17 | 30 | 0 |
| K822490 | DEFLECTING CYTOLOGY BRUSH | Van-Tec, Inc. | 1982-09-14 | 27 | 0 |
| K820869 | DISPOSABLE #11 SCALPEL BLADE W/SHORT | Van-Tec, Inc. | 1982-05-05 | 37 | 0 |
| K820865 | VAN-TEC FASCIAL DILATOR | Van-Tec, Inc. | 1982-05-05 | 37 | 0 |
| K820870 | URETERAL STANT SET | Van-Tec, Inc. | 1982-04-26 | 28 | 1 |
| K820868 | URETERAL CATHETER CONNECTOR | Van-Tec, Inc. | 1982-04-26 | 28 | 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