← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DQK — Computer, Diagnostic, Programmable

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1425
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
44
510(K)/PMA CLEARANCES
510k: 44
0
RECALL ENTRIES

Recent clearances

K262006Abbott Medical · 510k2026-07-15
K252978Synergen Technology Labs, LLC · 510k2026-07-09
K253463Implicity, Inc. · 510k2026-07-02
K261119Imricor Medical Systems, Inc. · 510k2026-06-30
K253088Micropace Pty, Ltd. · 510k2026-06-12
K261329Centerline Biomedical · 510k2026-06-10
K252859iRhythm Technologies, Inc. · 510k2026-05-29
K260212ABBOTT MEDICAL · 510k2026-04-20

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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