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510(k) K250765

AViTA Arm Type Blood Pressure Monitor Cuff by Avita Corporation — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2025
Date Received
March 13, 2025
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 Avita Corporation

  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K242455 — AViTA Pulse Oximeter (SP62B) (February 19, 2025)
  • K241852 — Nasal Aspirator (NS 13) (December 31, 2024)
  • K242193 — Arm Type Blood Pressure Monitor (BPM82) (October 22, 2024)
  • K223399 — AViTA Pulse Oximeter (May 20, 2024)
  • K200346 — Wrist Type Blood Pressure Monitor (December 17, 2020)
  • K180155 — Arm Type Blood Pressure Monitor (August 3, 2018)
  • K172427 — AViTA Radar Thermo NT16 Series IR Thermometer (April 19, 2018)
  • K112825 — AVITA ARM TYPE BLOOD PRESSURE MONITOR (January 18, 2012)
  • K110559 — AVITA INFRARED THEROMETER WITH BLUETOOTH (January 6, 2012)

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)
  • 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)
  • K230859 — Aneroid Sphygmomanometer (June 28, 2023)