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510(k) K831479

METAL-BACKED ACETABULAR CUP by Dow Corning Corp. Healthcare Industries Materials — Product Code DXQ

K831479 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "METAL-BACKED ACETABULAR CUP". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code DXQ (Blood Pressure Cuff), a Class II device regulated under 21 CFR 870.1120. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1983
Date Received
May 9, 1983
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 Dow Corning Corp. Healthcare Industries Materials

  • K853186 — SILASTIC INFLATABLE BONE PLUG H.P. (September 24, 1985)
  • K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (June 19, 1985)
  • K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (May 1, 1985)
  • K843995 — TF-II HIP PROSTHESIS (April 23, 1985)
  • K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (December 20, 1984)
  • K840357 — SSA HIP PROSTHESIS (February 17, 1984)
  • K812864 — SILASTIC VOICE PROSTHESIS (November 24, 1981)
  • K812053 — SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (August 18, 1981)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)
  • K801175 — SILASTIC II MAMMARY IMPLANT (December 18, 1980)

Other clearances for product code DXQ

  • K254287 — Medline Reusable Blood Pressure Cuff (June 22, 2026)
  • K260747 — YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff (May 6, 2026)
  • 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)

FDA data resources