510(k) Report

FDA applicant

Mac Medical

Deer Field, IL2 decisions2008–20190 recalls

FDA records 2 decisions for Mac Medical (Deer Field, IL) from 2008 to 2019: 2 510(k) clearances. Most are in product codes LHC (Warmer, Irrigation Solution) and LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mac Medical, Inc.”.

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 Mac Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2008: 12019: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Mac Medical by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mac Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LHCWarmer, Irrigation Solution1decision
  • LGZWarmer, Thermal, Infusion Fluid1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K180842MAC Medical D-Series Blanket and Solution Warming CabinetsMac Medical, Inc. · 2019
  • K080609SWC/DWC Warming CabinetsMac Medical · 2008

The one decision as Mac Medical →The one decision as Mac Medical, Inc. →