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510(k) K951039

BLOOD PRESSURE CUFF 1 by Pedia Pals, Inc. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1995
Date Received
March 6, 1995
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 Pedia Pals, Inc.

  • K951040 — BLOOD PRESSURE CUFF 2 (October 31, 1995)
  • K951041 — BLOOD PRESSURE CUFF 3 (October 31, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K950086 — PEDIA PALS, INCORPORATED (February 7, 1995)
  • K911650 — PEDIA PALS (October 17, 1991)

Other clearances for product code DXQ

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  • 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)
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  • K231961 — NIBPCuff (August 30, 2023)