Van-Tec, Inc.: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Van-Tec, Inc.” (first 1982, latest 1988), across 25 product codes in 3 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 10 | 10 |
| KOD | Catheter, Urological | 8 | 8 |
| EZN | Dilator, Catheter, Ureteral | 4 | 4 |
| KNW | Instrument, Biopsy | 4 | 4 |
| FAD | Stent, Ureteral | 3 | 3 |
| KOB | Catheter, Suprapubic (And Accessories) | 2 | 2 |
| KOE | Dilator, Urethral | 2 | 2 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 | 2 |
| EMF | Knife, Surgical | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
Plus 15 more product codes.
Review panels
Most recent Van-Tec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880099 | VAN-TEC BLADDER EVACUATOR | KQT | 1988-03-02 | 50 |
| K880098 | VAN-TEC AUTO BIOPSY NEEDLE | KNW | 1988-03-02 | 50 |
| K880096 | VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP | KNW | 1988-03-02 | 50 |
| K880095 | BERGER PROSTATE CULTURE CYTOLOGY BRUSH | FDX | 1988-03-02 | 50 |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | EMF | 1988-02-29 | 48 |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | KOD | 1988-02-11 | 125 |
| K871779 | HELICAL STONE BASKET (DISPOSABLE) | FFL | 1987-06-17 | 42 |
| K871777 | VAN-TEC REUSABLE HELICAL STONE BASKET | FFL | 1987-06-17 | 42 |
| K870696 | VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH | FFL | 1987-03-30 | 39 |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | FBO | 1987-03-30 | 39 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Van-Tec, Inc..
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 Van-Tec, Inc.?
FDA lists 52 510(k) clearances under the applicant name “Van-Tec, Inc.” (first 1982, latest 1988), across 25 product codes in 3 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 Van-Tec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Van-Tec, Inc. is 44 days.
Which FDA product codes appear under Van-Tec, Inc.?
The most frequent FDA product codes under this applicant name are FFL (Dislodger, Stone, Basket, Ureteral, Metal, 10); KOD (Catheter, Urological, 8); EZN (Dilator, Catheter, Ureteral, 4).
Next steps
- See all 52 Van-Tec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FFL, Van-Tec, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.