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510(k) K922819

INFANT DISPOSABLE BAG MASK RESUSCITATOR by Life Support Products, Inc. — Product Code BTM

K922819 is an FDA 510(k) premarket notification submitted by Life Support Products, Inc. for the device "INFANT DISPOSABLE BAG MASK RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on November 24, 1993. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Life Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1993
Date Received
June 11, 1992
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 Life Support Products, Inc.

  • K941870 — LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 (January 9, 1995)
  • K941871 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 (January 9, 1995)
  • K940934 — LIFE VAC (May 3, 1994)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932200 — LSPI AUTOMATIC VENTILATOR (November 24, 1993)
  • K932199 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000 (November 24, 1993)
  • K922691 — LSP (MODEL 554) BAG MASK RESUSCITATOR (November 24, 1993)
  • K921553 — LSPI INFANT BAG MASK (October 19, 1992)
  • K924217 — LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED (September 17, 1992)
  • K921107 — AUTOVAC (September 17, 1992)

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)

FDA data resources