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FDA PRODUCT CODE · CLASS II
DXQ — Blood Pressure Cuff
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
DEVICE CLASS
Class II
REGULATION
21 CFR 870.1120
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K254287Medline Industries, LP · 510k2026-06-22
K260747Nihon Kohden Corporation · 510k2026-05-06
K253089Shenzhen Best Electronics Co., Ltd. · 510k2026-02-13
K253964Unimed Medical Supplies, Inc. · 510k2026-01-09
K251745Baxter Healthcare Corporation · 510k2025-12-16
K250765Avita Corporation · 510k2025-09-03
K251045Unimed Medical Supplies, Inc. · 510k2025-07-15
K242623Shenzhen Medke Technology Co., Ltd. · 510k2024-10-31
Related on SPEQ
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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