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510(k) K142489

Unimed Disposable ECG lead wires by Unimed Medical Supplies, Inc. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2014
Date Received
September 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

Other clearances by Unimed Medical Supplies, Inc.

  • K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N) (January 9, 2026)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)
  • K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
  • K243086 — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reus (February 20, 2025)
  • K242580 — Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip (February 6, 2025)
  • K222213 — Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, (December 19, 2022)

Other clearances for product code DSA

  • K254114 — Baylis Connector Cable (January 18, 2026)
  • K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abb (December 1, 2025)
  • K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, (September 30, 2025)
  • K242986 — SpO2 Extension Cable (May 2, 2025)
  • K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 98980 (January 17, 2025)
  • K240087 — RT Carbon ECG Leads (September 13, 2024)
  • K240377 — LIFEPAK® ECG Cables (May 7, 2024)
  • K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack (April 30, 2024)
  • K222712 — Fogg System Patient Monitoring Cables (November 22, 2023)
  • K230571 — RFP-100A Connector Cable (Single Use) (May 30, 2023)