510(k) Report

FDA applicant

Uhi Corp.

Mchenry, IL3 decisions1982–19842 recalls

FDA records 3 decisions for Uhi Corp. (Mchenry, IL) from 1982 to 1984: 3 510(k) clearances. Most are in product codes INX (Bed, Air Fluidized) and KME (Bedding, Disposable, Medical). 2 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Uhi Corp. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Uhi 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?

  • INXBed, Air Fluidized2decisions
  • KMEBedding, Disposable, Medical1decision

What has FDA decided for it lately?

  • K843389Clinitron Air Fluidized Support J-101UDUhi Corp. · 1984
  • K821835Barrier Burn SheetUhi Corp. · 1982
  • K813584Clinitron Air Fluidized Support SystemUhi Corp. · 19822 recalls

All 3 as Uhi Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K813584CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure…Jun 24, 2009
  • K813584CLINITRON CII Air Fluidized Therapy unit.May 5, 2003