Home / 510(k) Clearances / K881086

510(k) K881086

LIFEGUARD MOUTH TO MASK RESUSCITATOR by Lifeguard Medical Products, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1988
Date Received
March 14, 1988
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 Lifeguard Medical Products, Inc.

  • K013421 — LIFEGUARD NASAL CPAP MASK AND ACCESSORIES (January 8, 2002)
  • K915296 — MONOPOLAR ELECTRODE (September 3, 1992)
  • K920471 — LEVY ARTICULATING RETRACTOR (June 23, 1992)
  • K915505 — REGULATOR FLOWMETER (April 22, 1992)
  • K915297 — TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM (February 11, 1992)
  • K915298 — SUCTION/IRRIGATION CANNULA; CATLOG #532.00 (January 23, 1992)
  • K880958 — LIFEGUARD BACTERIAL AND VIRAL FILTER (April 27, 1988)
  • K881087 — LIFEGUARD SINGLE USE MANUAL RESUSCITATORS (April 14, 1988)
  • K880959 — LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY (April 14, 1988)
  • K863711 — REGULATOR OXYGEN MECHANICAL (January 27, 1987)

Other clearances for product code BTM

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • 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)