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510(k) K953953

DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF by Deroyal Industries, Inc. — Product Code KCY

K953953 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
August 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type

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  • K200631 — DeRoyal Temperature Monitoring Probe (December 23, 2020)
  • K200757 — Foley Catheter with Temperature Sensor (October 15, 2020)
  • K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Su (April 2, 2020)
  • K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal St (April 2, 2020)
  • K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover (January 21, 2020)
  • K173072 — Algidex Ag Silver Alginate Wound Dressing (April 4, 2018)
  • K171475 — DeRoyal Laprador Specimen Retrieval System (August 17, 2017)
  • K152978 — DeRoyal Angiography Kits (March 25, 2016)

Other clearances for product code KCY

  • K202919 — ATS 5000 Automatic Tourniquet Instrument (May 20, 2021)
  • K162365 — T-Cuff (February 16, 2017)
  • K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (August 9, 2013)
  • K112874 — EZ VEIN INFLATABLE TOURNIQUET (October 17, 2011)
  • K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (June 7, 2007)
  • K050411 — ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (September 2, 2005)
  • K012632 — TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (October 26, 2001)
  • K955552 — EXPRESSAIRE TORUNIQUET SYSTEM (January 5, 1996)
  • K954201 — BUONAFEDE PNEUMATIC SLEEVE (November 9, 1995)
  • K954103 — TOURNI-COMP (November 1, 1995)

FDA data resources