510(k) Report

FDA applicant

Cambridge Cognition, Ltd., US Agent: Clementi Associates, Ltd.

Bottisham, GB1 decision2017–20170 recalls

FDA records 1 decision for Cambridge Cognition, Ltd., US Agent: Clementi Associates, Ltd. (Bottisham, GB) in 2017: 1 510(k) clearance. All are in product code PKQ (Computerized Cognitive Assessment Aid). 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, neurology panel, where it files most

How often FDA has decided Cambridge Cognition, Ltd., US Agent: Clementi Associates, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Cambridge Cognition, Ltd., US Agent: Clementi Associates… by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cambridge”

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