510(k) Report

FDA applicant

Care Electronics, Inc.

Boulder, CO3 decisions1993–20050 recalls

FDA records 3 decisions for Care Electronics, Inc. (Boulder, CO) from 1993 to 2005: 3 510(k) clearances. Most are in product codes KMI (Monitor, Bed Patient) and GEX (Powered Laser Surgical Instrument). Its devices cite 9 predicates, 1 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 hospital panel, where it files most

How often FDA has decided Care Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Care Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Care Electronics, 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?

  • KMIMonitor, Bed Patient1decision
  • GEXPowered Laser Surgical Instrument1decision
  • ILYLamp, Infrared, Therapeutic Heating1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K051681Dermillume Red, Model HR1000Care Electronics, Inc. · 20052cite it
  • K925529Wander CareCare Electronics, Inc. · 19931cites it
  • K043575Dermillume, Model PRO1000Care Electronics, Inc. · 20051cites it

What has FDA decided for it lately?

  • K051681Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
  • K043575Dermillume, Model PRO1000Care Electronics, Inc. · 2005
  • K925529Wander CareCare Electronics, Inc. · 1993

All 3 as Care Electronics, Inc. →