Vance Products, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Vance Products, Inc.” (first 1978, latest 1982), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 31 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KOD | Catheter, Urological | 5 | 5 |
| KOE | Dilator, Urethral | 4 | 4 |
| KOB | Catheter, Suprapubic (And Accessories) | 2 | 2 |
| EXB | Collector, Ostomy | 1 | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FGI | Catheter, Urethrographic, Male | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
Most recent Vance Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820313 | VPI-FAIR URETHRAL STENT | KOD | 1982-03-01 | 24 |
| K812995 | VANCE-JACOBELLIS MICROHEMATURIA CATHETER | KOD | 1982-03-01 | 126 |
| K813278 | VPI URETERAL DILATATION BALLON CATHETER | EZN | 1981-12-18 | 25 |
| K812785 | VANCE-AMBROSE RESECTOSCOPE FORCEPS | GEN | 1981-11-16 | 42 |
| K812057 | VANCE CYSTOSCOPIC | FBK | 1981-07-31 | 10 |
| K811833 | VNACE FASCIAL DILATOR SET | KOE | 1981-07-10 | 10 |
| K811454 | VANCE PROSTATIC ASPIRATION SET | KNW | 1981-06-09 | 18 |
| K810372 | VANCE DEFLECTABLE BIOPSY BRUSH SET | KOD | 1981-03-20 | 36 |
| K810371 | VANCE URETHAL DILATOR SET | KOE | 1981-03-20 | 36 |
| K810370 | POLLACK CHAIN CYSOURETHROGRAM SET | FGI | 1981-03-20 | 36 |
7 earlier clearances. See the full list in Caduvo.
Recalls
18 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2010-10-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vance Products, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Vance Products, Inc.” (first 1978, latest 1982), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vance Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vance Products, Inc. is 31 days.
Which FDA product codes appear under Vance Products, Inc.?
The most frequent FDA product codes under this applicant name are KOD (Catheter, Urological, 5); KOE (Dilator, Urethral, 4); KOB (Catheter, Suprapubic (And Accessories), 2).
Next steps
- See all 17 Vance Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOD, Vance Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.