510(k) Report

FDA applicant

Van-Tec, Inc.

Spencer, IN52 decisions1982–198814 recalls

FDA records 52 decisions for Van-Tec, Inc. (Spencer, IN) from 1982 to 1988: 52 510(k) clearances. Most are in product codes FFL (Dislodger, Stone, Basket, Ureteral, Metal) and KOD (Catheter, Urological). 14 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Van-Tec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Van-Tec, Inc. since 2007.

Recalls per year

5in 2009

2009: 5
2007high 5 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Van-Tec, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Van-Tec, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FFLDislodger, Stone, Basket, Ureteral, Metal10decisions
  • KODCatheter, Urological8decisions
  • KNWInstrument, Biopsy4decisions
  • EZNDilator, Catheter, Ureteral4decisions
  • FADStent, Ureteral3decisions
  • KOBCatheter, Suprapubic (And Accessories)2decisions

Also: KOE (2), OCZ (2), GDX (1), FBK (1), KOA (1), FBO (1).

Who builds on its devices?

Later devices cite its devices 11 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K851144Ureteral Dilation SetVan-Tec, Inc. · 19853cite it
  • K860267Mardis Dangler Ureteral Stent SetVan-Tec, Inc. · 19861cites it
  • K864874Segura Dretler BasketVan-Tec, Inc. · 19871cites it
  • K870694Van-Tec Open Ended Cone Tip Ureteral CatheterVan-Tec, Inc. · 19871cites it
  • K820865Van-Tec Fascial DilatorVan-Tec, Inc. · 19821cites it
  • K871779Helical Stone Basket (Disposable)Van-Tec, Inc. · 19871cites it

What has FDA decided for it lately?

  • K880096Van-Tec Aspiration Biopsy System W/Collection CupVan-Tec, Inc. · 1988
  • K880099Van-Tec Bladder EvacuatorVan-Tec, Inc. · 19881 recall
  • K880095Berger Prostate Culture Cytology BrushVan-Tec, Inc. · 1988
  • K880098Van-Tec Auto Biopsy NeedleVan-Tec, Inc. · 1988
  • K880094Van-Tec Endopyelotomy KnifeVan-Tec, Inc. · 1988
  • K874112Van-Tec Double Occlusion Balloon CatheterVan-Tec, Inc. · 1988
  • K871779Helical Stone Basket (Disposable)Van-Tec, Inc. · 1987
  • K871777Van-Tec Reusable Helical Stone BasketVan-Tec, Inc. · 1987

All 52 as Van-Tec, Inc. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K820870Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Mar 18, 2009
  • K860267Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Mar 18, 2009
  • K820867Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Mar 18, 2009
  • K820867Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Mar 18, 2009
  • K820867Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN #…Mar 18, 2009
  • K880099Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no.…Jun 30, 2006