510(k) Report

FDA applicant

Stat Medical Corp.

Mchenry, IL4 decisions1977–19780 recalls

FDA records 4 decisions for Stat Medical Corp. (Mchenry, IL) from 1977 to 1978: 4 510(k) clearances. Most are in product codes ILI (Sling, Arm) and FRL (Fiber, Medical, Absorbent). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Stat Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stat Medical 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?

  • ILISling, Arm1decision
  • FRLFiber, Medical, Absorbent1decision
  • IODComponents, Exercise1decision
  • FMPProtector, Skin Pressure1decision

What has FDA decided for it lately?

  • K780171Elbow ProtectorStat Medical Corp. · 1978
  • K771031Stroke SlingStat Medical Corp. · 1977
  • K771030Flexion MittensStat Medical Corp. · 1977
  • K770853Sterile CottonStat Medical Corp. · 1977

All 4 as Stat Medical Corp. →

Other applicant names beginning “Stat”

FDA records each applicant name separately; these may or may not be the same firm.

Stat Medical Devices 4Stat Path 4Stat Engineering 1Stat-Spin Technologies 1Stat Chem, Inc. 1