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510(k) K932851

DISPOSABLE PENILE BLOOD PRESSURE CUFFS by D. E. Hokanson, Inc. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1993
Date Received
June 10, 1993
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 D. E. Hokanson, Inc.

  • K041689 — POLYURETHANE BLOOD PRESSURE CUFFS (August 6, 2004)
  • K033156 — OB1 OBSTETRICAL DOPPLER (December 9, 2003)
  • K023707 — A16 BLOOD FLOW MEASUREMENT SYSTEM (February 12, 2003)
  • K982707 — EC6 PLETHYSMOGRAPH (August 26, 1998)
  • K973426 — ANS 2000 ECG MONITOR AND RESPIRATION PACER (August 12, 1998)
  • K970570 — NIVP3 (WINDOWS VERSION OF NIVP (October 3, 1997)
  • K932852 — NON INVASIVE VASCULAR PROGRAM (February 4, 1994)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K905367 — E-20 RAPID CUFF INFLATOR (March 6, 1991)
  • K901592 — MODEL MD-5 DOPPLER (October 22, 1990)

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)