Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

DXQ

Blood Pressure Cuff

Product code
DXQ
Device name
Blood Pressure Cuff
Device class
Class 2
21 CFR
21 CFR 870.1120
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
11
Summaries archived here
10 (direct download)
510(k) clearances (all years, FDA)
199 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (11)

Last three years. Most recent: 2026-06-22.

NumberDecision dateApplicantDevice nameSummary
K2542872026-06-22Medline Industries, LPMedline Reusable Blood Pressure CuffPDF
K2607472026-05-06Nihon Kohden CorporationYP-710T Series NIBP Cuff;YP-840T Series Disposable C…PDF
K2530892026-02-13Shenzhen Best Electronics Co., Ltd.NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-5…PDF
K2539642026-01-09Unimed Medical Supplies, Inc.Disposable Neonatal NIBP Cuff (U1681S-C51N)PDF
K2517452025-12-16Baxter Healthcare CorporationWelch Allyn FlexiPort Blood Pressure Cuffs (FlexiPor…PDF
K2507652025-09-03Avita CorporationAViTA Arm Type Blood Pressure Monitor CuffPDF
K2510452025-07-15Unimed Medical Supplies, Inc.Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposa…PDF
K2426232024-10-31Shenzhen Medke Technology Co., Ltd.Disposable Blood Pressure cuff; Reusable Blood Press…PDF
K2401652024-03-20Wenzhou Longwan Medical Device FactoryAneroid Sphygmomanometer with Stethoscope; Aneroid S…FDA
K2332762023-12-21Suzhou Minhua Medical Apparatus Suppli…Reusable Blood Pressure CuffPDF
K2327722023-11-29Shenzhen Plinma Technology Co. , Ltd.Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,120…PDF

10 summaries are archived here for direct download.

Official FDA classification page: DXQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).