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510(k) K143332

Fast Sphyg by Koven by Koven Technology, Inc. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2015
Date Received
November 20, 2014
Clearance Type
Traditional
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 Koven Technology, Inc.

  • K201114 — Bidop 7 (January 5, 2021)
  • K153762 — Smartdop XT6 (May 25, 2016)
  • K131623 — SMARTDOP XT (January 17, 2014)
  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)
  • K050601 — SMARTDOP 45 VASCULAR DOPPLER (April 15, 2005)
  • K031931 — ECHO SOUNDER EX-101EX 8 MHZ (February 13, 2004)
  • K031504 — ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX (July 18, 2003)
  • K023143 — ECHO SOUNDER, ES-102EX (December 19, 2002)
  • K010452 — BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T (February 12, 2002)
  • K982986 — TUBING BLOOD FLOW METER MODEL NUMBER HD-800 (November 24, 1998)

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)