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510(k) K954866

MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR by Mercury Medical — Product Code BTM

K954866 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR". The FDA issued a decision of Substantially Equivalent on Jan 30, 1996. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Mercury Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 30, 1996
Date Received
Oct 24, 1995
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 Mercury Medical

  • K142096 — T-PIECE RESUSCITATOR (Oct 17, 2014)
  • K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR (Apr 6, 2010)
  • K090710 — MERCURY CPAP (Aug 20, 2009)
  • K083056 — NEO-STAT CO2 <KG (Feb 23, 2009)
  • K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (Feb 3, 2004)
  • K031814 — STATCO2METER, MODEL 10-55372 (Aug 14, 2003)
  • K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (Jul 30, 2003)
  • K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 (Nov 4, 2002)
  • K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (Nov 3, 2000)
  • K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (Mar 1, 2000)

Other clearances for product code BTM

  • K251631 — The BAG manual resuscitator and accessories (Nov 24, 2025)
  • K243861 — butterflyBVM (Apr 25, 2025)
  • K221841 — EOlife® (Mar 18, 2023)
  • K212905 — Sotair Device (Aug 18, 2022)
  • K210288 — Disposable Manual Resuscitator (Aug 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (Dec 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 (Aug 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (Jan 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (Jan 13, 2012)

FDA data resources