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510(k) K040286

ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS by Ethox Corp. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2004
Date Received
February 6, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

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 Ethox Corp.

  • K031195 — CUF-COVER (TM) (October 10, 2003)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • K935633 — NO-MES (September 30, 1994)
  • K921946 — TUM-E-VAC BITE BLOCK (December 9, 1992)
  • K885220 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (September 25, 1989)
  • K894927 — SURGI SQUEEZ (September 11, 1989)
  • K883977 — SURGI-CUF STERILE/NON-STERILE DISPOSABLE (February 10, 1989)
  • K860599 — ETHOX LAVAGE TUBE (March 11, 1986)
  • K844988 — ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. (April 4, 1985)
  • K841512 — ETHOX RELIA-FLO 2001 ENTERAL FEED (May 21, 1984)

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)