Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vance Products, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
73 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820313 | VPI-FAIR URETHRAL STENT | Vance Products, Inc. | 1982-03-01 | 24 | 1 |
| K812995 | VANCE-JACOBELLIS MICROHEMATURIA CATHETER | Vance Products, Inc. | 1982-03-01 | 126 | 0 |
| K813278 | VPI URETERAL DILATATION BALLON CATHETER | Vance Products, Inc. | 1981-12-18 | 25 | 0 |
| K812785 | VANCE-AMBROSE RESECTOSCOPE FORCEPS | Vance Products, Inc. | 1981-11-16 | 42 | 0 |
| K812057 | VANCE CYSTOSCOPIC | Vance Products, Inc. | 1981-07-31 | 10 | 0 |
| K811833 | VNACE FASCIAL DILATOR SET | Vance Products, Inc. | 1981-07-10 | 10 | 1 |
| K811454 | VANCE PROSTATIC ASPIRATION SET | Vance Products, Inc. | 1981-06-09 | 18 | 0 |
| K810371 | VANCE URETHAL DILATOR SET | Vance Products, Inc. | 1981-03-20 | 36 | 0 |
| K810372 | VANCE DEFLECTABLE BIOPSY BRUSH SET | Vance Products, Inc. | 1981-03-20 | 36 | 0 |
| K810368 | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY | Vance Products, Inc. | 1981-03-20 | 36 | 0 |
| K810370 | POLLACK CHAIN CYSOURETHROGRAM SET | Vance Products, Inc. | 1981-03-20 | 36 | 0 |
| K810367 | KISH URETHRAL ILLUMINATED CATHETER SET | Vance Products, Inc. | 1981-03-20 | 36 | 0 |
| K803048 | VANCE UROSTOMY APPLIANCE | Vance Products, Inc. | 1980-12-22 | 21 | 0 |
| K792221 | VANCE PHILIPS FOLLOWER CATHETER & BOUGIE | Vance Products, Inc. | 1979-12-06 | 31 | 0 |
| K792220 | VANCE KIDNEY BIOPSY BRUSHES | Vance Products, Inc. | 1979-12-06 | 31 | 0 |
| K792219 | VANCE MALLEABLE TIP FILIFORM | Vance Products, Inc. | 1979-12-06 | 31 | 0 |
| K780765 | PERCUTANEOUS SURAPUBIC CATHETER | Vance Products, Inc. | 1978-07-17 | 73 | 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