510(k) Report

FDA applicant

Universal Medical Instrument Corp.

Ballston Spa, NY21 decisions1977–19960 recalls

FDA records 21 decisions for Universal Medical Instrument Corp. (Ballston Spa, NY) from 1977 to 1996: 21 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQO (Catheter, Intravascular, Diagnostic). 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, cardiovascular panel, where it files most

How often FDA has decided Universal Medical Instrument Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Universal Medical Instrument Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Universal Medical Instrument Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter6decisions
  • DQOCatheter, Intravascular, Diagnostic3decisions
  • HIOSampler, Amniotic Fluid (Amniocentesis Tray)2decisions
  • DQXWire, Guide, Catheter2decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • DWSInstruments, Surgical, Cardiovascular1decision

Also: LYY (1), FGE (1), DXE (1), IME (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K850820Percutaneous Catheter Introducer W/Cath-Seal & SidUniversal Medical Instrument Corp. · 19851cites it
  • K822586Teflon Coated Guide Wires & CatheterUniversal Medical Instrument Corp. · 19821cites it

What has FDA decided for it lately?

  • K962180Cath SealUniversal Medical Instrument Corp. · 1996
  • K935077Cath-SealUniversal Medical Instrument Corp. · 1994
  • K897128Umi Braided Catheter ConnectorUniversal Medical Instrument Corp. · 1990
  • K881796Umi Disposable Butterfly Style Puncture NeedleUniversal Medical Instrument Corp. · 1988
  • K863178Umi Steerable Torque Guide WireUniversal Medical Instrument Corp. · 1986
  • K861984Umi Cath-Seal, 13+14F & Transseptal Catheter IntroUniversal Medical Instrument Corp. · 1986
  • K860168Umi (Franseen,Westcott,Greene,Menghini)Bio. NeedleUniversal Medical Instrument Corp. · 1986
  • K851088Umi Angiographic CatheterUniversal Medical Instrument Corp. · 1985

All 21 as Universal Medical Instrument Corp. →