510(k) Report

FDA applicant

Cambridge Sensors Limited

Huntingdon, Cambridgeshire, GB3 decisions2007–20121 recall

FDA records 3 decisions for Cambridge Sensors Limited (Huntingdon, Cambridgeshire, GB) from 2007 to 2012: 3 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 3 predicates, 3 of them its own earlier devices. 1 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2012

2007: 12009: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cambridge Sensors 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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Other applicant names beginning “Cambridge”

FDA records each applicant name separately; these may or may not be the same firm.