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510(k) K031416

CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF by Clearmedical, Inc. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2003
Date Received
May 5, 2003
Clearance Type
Traditional
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 Clearmedical, Inc.

  • K033579 — REPROCESSED MULTIPLE CLIP APPLIERS (July 11, 2005)
  • K033578 — REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (July 11, 2005)
  • K033591 — REPROCESSED TROCARS (June 3, 2005)
  • K033592 — REPROCESSED SURGICAL SCISSORS AND GRASPERS (July 27, 2004)
  • K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (November 20, 2003)
  • K012600 — CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L (July 3, 2002)
  • K012609 — CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 (July 3, 2002)
  • K012622 — CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 (July 3, 2002)
  • K012601 — CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF C (February 6, 2002)
  • K012621 — CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT (February 6, 2002)

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)