510(k) Report

FDA applicant

Ulti-Med Intl., Inc.

Glendale Hts., IL21 decisions1983–20110 recalls

FDA records 21 decisions for Ulti-Med Intl., Inc. (Glendale Hts., IL) from 1983 to 2011: 21 510(k) clearances. Most are in product codes KDD (Kit, Surgical Instrument, Disposable) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Ulti-Med Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ulti-Med Intl., Inc. 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?

  • KDDKit, Surgical Instrument, Disposable3decisions
  • KKXDrape, Surgical, Antimicrobial3decisions
  • NABGauze / Sponge,Nonresorbable For External Use3decisions
  • MEGSyringe, Antistick1decision
  • FXPCover, Shoe, Operating-Room1decision
  • FRGWrap, Sterilization1decision

Also: FMI (1), LYZ (1), GDY (1), LRP (1), FMC (1), FXO (1).

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K103011Ulticare Safety Insulin SyringeUlti-Med Intl., Inc. · 20111cites it

What has FDA decided for it lately?

  • K103011Ulticare Safety Insulin SyringeUlti-Med Intl., Inc. · 2011
  • K923176Surgical Instrument Kit, DisposableUlti-Med Intl., Inc. · 1993
  • K923175Surgical Instrument Kit, DisposableUlti-Med Intl., Inc. · 1993
  • K920989Surgical Instrument Kit, DisposableUlti-Med Intl., Inc. · 1992
  • K922828Ulcer Wound TrayUlti-Med Intl., Inc. · 1992
  • K914244Sterile Custom Surgical KitsUlti-Med Intl., Inc. · 1992
  • K914431Absorbent FiberUlti-Med Intl., Inc. · 1991
  • K912692Conforming BandageUlti-Med Intl., Inc. · 1991

All 21 as Ulti-Med Intl., Inc. →