510(k) K080854

DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 by Suntech Medical, Inc. — Product Code DXQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 20, 2008
Date Received: March 27, 2008
Clearance Type: Abbreviated
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Blood Pressure Cuff
Device Class: Class II
Regulation Number: 870.1120
Review Panel: CV
Submission Type

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.

Other clearances by Suntech Medical, Inc.

K160439 — SunTech CT40 Spot-check Vital Signs Device (July 6, 2016)
K151520 — Oscar 2 (February 19, 2016)
K122401 — TANGO M2 BLOOD PRESSURE MONITOR (November 2, 2012)
K070750 — 247 BP DEVICE (May 2, 2007)
K060820 — CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 (June 7, 2006)
K053209 — TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM (January 5, 2006)
K051904 — ALL PURPOSE CUFF, MODEL 222APC (September 9, 2005)

Other clearances for product code DXQ

K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-12 (February 13, 2026)
K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N) (January 9, 2026)
K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
K250765 — AViTA Arm Type Blood Pressure Monitor Cuff (September 3, 2025)
K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (October 31, 2024)
K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (March 20, 2024)
K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,120 (November 29, 2023)
K231961 — NIBPCuff (August 30, 2023)