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510(k) K251631

The BAG manual resuscitator and accessories by Laerdal Medical AS — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2025
Date Received
May 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Laerdal Medical AS

  • K232111 — NeoBeat, NeoBeat Mini (June 25, 2024)
  • 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)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
  • K023805 — LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 (February 11, 2003)
  • K001742 — RESUSCI INFLATE-A-SHIELD CPR BARRIER (October 6, 2000)
  • K993668 — LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 (December 20, 1999)
  • K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (September 5, 1996)

Other clearances for product code BTM

  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • K212905 — Sotair Device (August 18, 2022)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)
  • K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (January 28, 2011)