510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161328Substantially Equivalent

Cantab Mobile

Cambridge Cognition, Ltd., US Agent: Clementi Associates, Ltd., Bottisham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161328 is the FDA 510(k) clearance record for Cantab Mobile, a class II device, cleared for Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. on under FDA product code PKQ (Computerized Cognitive Assessment Aid). FDA's definition for product code PKQ reads: "The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose...". FDA records list one 510(k) clearance for Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. As of , FDA records show no recalls naming K161328.

Clearance record

Decision date
Received
(246 days to decision)
Product code
PKQ Computerized Cognitive Assessment Aid
Regulation
21 CFR 882.1470
Device class
Class II
Review panel
Neurology
Applicant
Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. Tunbridge Ct., Tunbridge Ln., Bottisham, GB
510(k) summary
Statement
Third party review
No

Clearances, product code PKQ

Trailing 12 months

FDA records hold no clearances under product code PKQ in the trailing twelve months.

FDA records show no clearances under product code PKQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PKQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260