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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interoperable Automated Glycemic Controller
510(k) Number K261896
Device Name iOS CamAPS FX
Applicant
CamDiab
20-22 Wenlock Rd.
London,  GB N1 7GU
Applicant Contact Roman Hovorka
Correspondent
MCRA,LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Nima Akhlaghi
Regulation Number862.1356
Classification Product Code
QJI  
Date Received06/08/2026
Decision Date 09/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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