510(k) Report

FDA applicant

Sk Med

Van Nuys, CA4 decisions1998–20040 recalls

FDA records 4 decisions for Sk Med (Van Nuys, CA) from 1998 to 2004: 4 510(k) clearances. All are in product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Sk Med since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sk Med 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?

  • BZRMixer, Breathing Gases, Anesthesia Inhalation4decisions

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.

  • K031860SK Med ME202 Monitoring MixerSk Med · 20041cites it

What has FDA decided for it lately?

  • K031860SK Med ME202 Monitoring MixerSk Med · 2004
  • K031707SK Med M201 Plus MixerSk Med · 2003
  • K022864SK Med M201 MixerSk Med · 2003
  • K974372Air Oxyge MixerSk Med · 1998

All 4 as Sk Med →