510(k) Report

FDA applicant

MD Diagnostics Limited

Maidstone, GB2 decisions2018–20190 recalls

FDA records 2 decisions for MD Diagnostics Limited (Maidstone, GB) from 2018 to 2019: 2 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase). Its devices cite 3 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, anesthesiology panel, where it files most

How often FDA has decided MD Diagnostics Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — MD Diagnostics Limited by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CAHFilter, Bacterial, Breathing-Circuit1decision
  • CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase1decision

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?

  • K190022SafeBreath Filter MouthpieceMD Diagnostics Limited · 2019
  • K171129CO Check Pro, CO ScreenMD Diagnostics Limited · 2018

All 2 as MD Diagnostics Limited →