510(k) Report

FDA applicant

Caf Medical Solutions, Inc.

Hockley, TX3 decisions2022–20220 recalls

FDA records 3 decisions for Caf Medical Solutions, Inc. (Hockley, TX) in 2022: 3 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and DPS (Electrocardiograph). Since 2016 its 510(k)s took a median of 45 days from receipt to decision, against 189 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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, cardiovascular panel, where it files most

How often FDA has decided Caf Medical Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2022: 3
2022high 3 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Caf Medical Solutions, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions
  • DPSElectrocardiograph1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 45 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 189 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc. · 2022
  • K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc. · 2022
  • K220362LE-12CHCaf Medical Solutions, Inc. · 2022

All 3 as Caf Medical Solutions, Inc. →