510(k) Report

FDA applicant

Pos-T-Vac, Inc.

Dodge City, KS12 decisions1994–20020 recalls

FDA records 12 decisions for Pos-T-Vac, Inc. (Dodge City, KS) from 1994 to 2002: 12 510(k) clearances. Most are in product codes LKY (Device, External Penile Rigidity) and KZH (Introducer, Syringe Needle). No recall is 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 Pos-T-Vac, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pos-T-Vac, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pos-T-Vac, 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?

  • LKYDevice, External Penile Rigidity11decisions
  • KZHIntroducer, Syringe Needle1decision

Who builds on its devices?

Later devices cite its devices 10 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.

  • K960828Pos-T-Vac B-10 Band KitPos-T-Vac, Inc. · 19966cite it
  • K960342Pos-T-Vac Avp-1000 & MVP-700Pos-T-Vac, Inc. · 19962cite it
  • K961309Pos-T-Vac ID-300Pos-T-Vac, Inc. · 19961cites it
  • K981180Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac B-25 Ring Kit and Pos-T-Vac B-10 Ring KitPos-T-Vac, Inc. · 19981cites it

What has FDA decided for it lately?

  • K020258Support SleevePos-T-Vac, Inc. · 2002
  • K020154VT-1Pos-T-Vac, Inc. · 2002
  • K012670Boss 2000-3 Vacuum Erection DevicePos-T-Vac, Inc. · 2001
  • K012672Boss-2000-2 Vacuum Erection DevicePos-T-Vac, Inc. · 2001
  • K983245Pos-T-Vac (Avp-1000)Pos-T-Vac, Inc. · 1998
  • K983246Pos-T-Vac (Ivp-600)Pos-T-Vac, Inc. · 1998
  • K981011Pos-T-Vac (Rejoyn Vacuum Erection Device)Pos-T-Vac, Inc. · 1998
  • K981180Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac B-25 Ring Kit and Pos-T-Vac B-10 Ring KitPos-T-Vac, Inc. · 1998

All 12 as Pos-T-Vac, Inc. →