FDA Product Code BTL: Ventilator, Emergency, Powered (resuscitator)
Leading manufacturers include Allied Healthcare Products, Inc., Vortran Medical Technology 1, Inc. and Impact Instrumentation, 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
Cleared
Apr 04, 2025
VentStar Resus heated (N) (MP17030)
Draegerwerk AG & CO Kgaa
Anesthesiology
203d
Cleared
May 24, 2023
Oxymag - Transport and Emergency Ventilator
Magnamed Tecnologia Medica S/A
Anesthesiology
352d
Cleared
Feb 11, 2021
VORTRAN GO2VENT with PEEP Valve
Vortran Medical Technology 1, Inc.
Anesthesiology
189d
Cleared
Nov 20, 2020
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
Weinmann Emergency Medical Technology GmbH + Co. KG
Anesthesiology
367d
Cleared
Jan 18, 2019
Puffin Lite Infant Resuscitation System
International Biomedical
Anesthesiology
86d
Cleared
Nov 16, 2018
SafeT T-Piece Resuscitator
Ventlab, LLC
Anesthesiology
385d
Cleared
Apr 10, 2017
VORTRAN GO2VENT
Vortran Medical Technology 1, Inc.
Anesthesiology
168d
Cleared
Apr 09, 2014
EMERGENCY PORTABLE VENTILATOR
Allied Healthcare Products, Inc.
Anesthesiology
356d
Cleared
Apr 02, 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
Allied Healthcare Products, Inc.
Anesthesiology
274d
Cleared
May 20, 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
Allied Healthcare Products, Inc.
Anesthesiology
97d
Cleared
May 18, 2009
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
Allied Healthcare Products, Inc.
Anesthesiology
173d
Cleared
May 14, 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
Allied Healthcare Products, Inc.
Anesthesiology
178d
Cleared
Aug 15, 2008
MASS CASUALTY VENTILATOR, MODEL MCV100
Allied Healthcare Products, Inc.
Anesthesiology
218d
Cleared
May 23, 2008
VAR MONITOR
Vortran Medical Technology 1, Inc.
Anesthesiology
185d
Cleared
Mar 06, 2008
PORTABLE VENTILATOR, MODEL EPV-100
Allied Healthcare Products, Inc.
Anesthesiology
210d
Cleared
Jul 13, 2007
AUTOVENT 4000 WITH CPAP
Allied Healthcare Products, Inc.
Anesthesiology
128d
Cleared
May 03, 2007
AUTOVENT MODEL 4000
Allied Healthcare Products, Inc.
Anesthesiology
111d
Cleared
Apr 20, 2007
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
Ohmeda Medical
Anesthesiology
88d
Cleared
Oct 28, 2005
UNI-VENT MODEL 73X
Impact Instrumentation, Inc.
Anesthesiology
147d
Cleared
Jul 15, 2004
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
Vortran Medical Technology 1, Inc.
Anesthesiology
43d
Cleared
Mar 26, 2004
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
Impact Instrumentation, Inc.
Anesthesiology
235d
Cleared
Jul 05, 2000
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
Vortran Medical Technology 1, Inc.
Anesthesiology
61d
Cleared
Aug 17, 1999
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
Instrumentation Industries, Inc.
Anesthesiology
84d
Cleared
Jun 12, 1998
RESPIRTECHPRO
Vortran Medical Technology 1, Inc.
Anesthesiology
235d
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 →