510(k) Report

FDA applicant

Deltex Medical Limited

Chichester, West Sussex, GB9 decisions1995–20180 recalls

FDA records 9 decisions for Deltex Medical Limited (Chichester, West Sussex, GB) from 1995 to 2018: 9 510(k) clearances. Most are in product codes DPW (Flowmeter, Blood, Cardiovascular) and DPT (Probe, Blood-Flow, Extravascular). Its devices cite 14 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Deltex Medical”.

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

FDA decisions per year

1in 2018

2009: 12011: 12013: 12015: 22018: 1
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Deltex Medical Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Deltex Medical Limited’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?

  • DPWFlowmeter, Blood, Cardiovascular6decisions
  • DPTProbe, Blood-Flow, Extravascular3decisions

Whose devices does it build on?

Its devices cite 14 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 12 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.

  • K111542Deltex Medical Cardioq EdmDeltex Medical Limited · 20113cite it
  • K031706Cardioq, Model 9051-7005Deltex Medical · 20033cite it
  • K132139Deltex Medical Cardioq-Edm+Deltex Medical Limited · 20132cite it
  • K951369EDMDeltex Medical · 19952cite it
  • K052989DP240 240 Hour Doppler ProbeDeltex Medical · 20062cite it
  • K073593I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015…Deltex Medical Limited · 20091cites it

What has FDA decided for it lately?

  • K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018
  • K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+Deltex Medical Limited · 2015
  • K142932Deltex Medical KDP72 Doppler ProbeDeltex Medical Limited · 2015
  • K132139Deltex Medical Cardioq-Edm+Deltex Medical Limited · 2013
  • K111542Deltex Medical Cardioq EdmDeltex Medical Limited · 2011
  • K073593I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015…Deltex Medical Limited · 2009
  • K052989DP240 240 Hour Doppler ProbeDeltex Medical · 2006
  • K031706Cardioq, Model 9051-7005Deltex Medical · 2003

All 6 as Deltex Medical Limited →All 3 as Deltex Medical →