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510(k) K123597

TRUECPR COACHING DEVICE by Physio-Control, Inc. — Product Code LIX

K123597 is an FDA 510(k) premarket notification submitted by Physio-Control, Inc. for the device "TRUECPR COACHING DEVICE". The FDA issued a decision of Substantially Equivalent on April 17, 2013. The device falls under product code LIX (Aid, Cardiopulmonary Resuscitation), a Class II device regulated under 21 CFR 870.5210. Physio-Control, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2013
Date Received
November 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aid, Cardiopulmonary Resuscitation
Device Class
Class II
Regulation Number
870.5210
Review Panel
CV
Submission Type

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software

Other clearances by Physio-Control, Inc.

  • K253099 — LIFEPAK 15 AC Power Adapter (41577-000333) (October 14, 2025)
  • K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack (April 30, 2024)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (August 21, 2013)
  • K122600 — LIFEPAK 1000 DEFIBRILLATOR (October 11, 2012)
  • K103567 — LIFEPAK 15 MONITOR/DEFIBRILLATOR (March 22, 2011)
  • K102972 — LIFEPAK 12 (December 22, 2010)
  • K102757 — LIFENET SYSTEM (November 5, 2010)
  • K093925 — LIFENET SYSTEM (January 12, 2010)

Other clearances for product code LIX

  • K201581 — CPR BAND (March 6, 2021)
  • K183348 — Reusable Silicone Cover CPRmeter 2 (December 17, 2018)
  • K173886 — CPRmeter 2 CPR Feedback Device (March 23, 2018)
  • K151702 — Reusable Full Silicone Cover (August 13, 2015)
  • K123248 — CPR RSQ ASSIST (December 10, 2013)
  • K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
  • K112660 — POCKETCPR (May 10, 2012)
  • K092408 — RHYTHM OF LIFE, MODEL R0901-05 (October 14, 2009)
  • K071321 — POCKETCPR (September 12, 2007)
  • K010526 — MODIFICATION TO THE GRIP (December 13, 2001)

FDA data resources