BTL · Class II · 21 CFR 868.5925

FDA Product Code BTL: Ventilator, Emergency, Powered (resuscitator)

Leading manufacturers include Allied Healthcare Products, Inc., Pneupac , Ltd. and Life Support Products, Inc..

100
Total
100
Cleared
156d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 203d recently vs 156d historically

FDA 510(k) Cleared Ventilator, Emergency, Powered (resuscitator) Devices (Product Code BTL)

100 devices
1–24 of 100
Cleared Apr 04, 2025
VentStar Resus heated (N) (MP17030)
K242769
Draegerwerk AG & CO Kgaa
Anesthesiology · 203d
Cleared May 24, 2023
Oxymag - Transport and Emergency Ventilator
K221634
Magnamed Tecnologia Medica S/A
Anesthesiology · 352d
Cleared Feb 11, 2021
VORTRAN GO2VENT with PEEP Valve
K202219
Vortran Medical Technology 1, Inc.
Anesthesiology · 189d
Cleared Nov 20, 2020
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
K193191
Weinmann Emergency Medical Technology GmbH + Co. KG
Anesthesiology · 367d
Cleared Jan 18, 2019
Puffin Lite Infant Resuscitation System
K182956
International Biomedical
Anesthesiology · 86d
Cleared Nov 16, 2018
SafeT T-Piece Resuscitator
K173373
Ventlab, LLC
Anesthesiology · 385d
Cleared Jun 06, 2017
MOVES SLC
K161420
Thornhill Research, Inc.
Anesthesiology · 379d
Cleared Apr 10, 2017
VORTRAN GO2VENT
K162968
Vortran Medical Technology 1, Inc.
Anesthesiology · 168d
Cleared Mar 16, 2015
O-TWO E700,O-TWO E600,O-TWO E500
K141595
O-Two Medical Technologies, Inc.
Anesthesiology · 276d
Cleared Oct 17, 2014
T-PIECE RESUSCITATOR
K142096
Mercury Medical
Anesthesiology · 77d
Cleared May 29, 2014
MOVES SLC
K140049
Thornhill Research, Inc.
Anesthesiology · 140d
Cleared May 28, 2014
LIFEBORNE INFANT RESUSCITATOR
K140707
International Biomedical
Anesthesiology · 69d
Cleared Apr 09, 2014
EMERGENCY PORTABLE VENTILATOR
K131098
Allied Healthcare Products, Inc.
Anesthesiology · 356d
Cleared Apr 02, 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
K132021
Allied Healthcare Products, Inc.
Anesthesiology · 274d
Cleared Mar 26, 2014
VENTRAIN
K132759
Dolphys Medical B.V.
Anesthesiology · 203d
Cleared Mar 21, 2014
SAVE II, SAVE II BASIC
K131877
Automedx, Inc.
Anesthesiology · 269d
Cleared Sep 16, 2013
PNEUPAC PARAPAC PLUS
K123957
Smiths Medical International , Ltd.
Anesthesiology · 269d
Cleared Dec 22, 2011
MANUJET III
K112783
VBM Medizintechnik GmbH
Anesthesiology · 87d
Cleared Apr 06, 2011
RESUSCI FLOW
K102542
Atom Medical Corporation
Anesthesiology · 215d
Cleared May 06, 2010
CAREVENT HANDHELD CPAP SYSTEM
K093862
O-Two Medical Technologies, Inc.
Anesthesiology · 140d
Cleared Apr 06, 2010
MERCURY MEDICAL T-PIECE RESUSCITATOR
K093913
Mercury Medical, Inc.
Anesthesiology · 105d
Cleared Mar 26, 2010
MOVES
K093261
Thornhill Research, Inc.
Anesthesiology · 158d
Cleared Oct 07, 2009
ISPIRA RESUSCITATION UNIT
K092085
Neoforce Group, Inc.
Anesthesiology · 90d
Cleared May 20, 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356
Allied Healthcare Products, Inc.
Anesthesiology · 97d

About Product Code BTL - Regulatory Context

510(k) Submission Activity

100 total 510(k) submissions under product code BTL since 1977, with 100 receiving FDA clearance (average review time: 156 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - BTL Product Code

Recent submissions under BTL have taken an average of 203 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.

BTL devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →