ClearanceBrief
Panels › Anesthesiology › Product code BTL · Class 2

Ventilator, Emergency, Powered (Resuscitator)

Regulation 868.5925

0510(k)s in 12 months (100 all time)
0recalls in 12 months (29 all time)
27recalls that name a 510(k)
Get daily alerts for BTLSample briefCSV

Top companies in BTL

DateFirm and productCodeLinked 510(k)
Jan 10, 2025Mercury Enterprises, Inc. dba Mercury Medical
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Open, Classified
BTLK093913
Oct 2, 2024Mercury Enterprises, Inc. dba Mercury Medical
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Open, Classified
BTLK093913
Sep 20, 2024Smiths Medical ASD Inc.
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Open, Classified
BTLK123957
Sep 20, 2024Smiths Medical ASD Inc.
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Open, Classified
BTLK123957
Sep 11, 2024Smiths Medical ASD Inc.
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Open, Classified
BTLK123957
Sep 11, 2024Smiths Medical ASD Inc.
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
Open, Classified
BTLK123957
Mar 19, 2024Smiths Medical ASD Inc.
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Open, Classified
BTLK123957
Mar 19, 2024Smiths Medical ASD Inc.
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Open, Classified
BTLK123957
Jul 15, 2021Smiths Medical ASD Inc.
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Terminated
BTLK123957
Jun 26, 2020Precision Valve & Automation,Inc
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to prov
Open, Classified
BTLNone listed
Apr 4, 2019O-Two Medical Technologies, Inc.
e700 Automatic Transport Ventilator, Model Number 01EVE700
Terminated
BTLK141595
Apr 4, 2019O-Two Medical Technologies, Inc.
e600 Automatic Transport Ventilator, Model Number 01EVE600
Terminated
BTLK141595
Apr 4, 2019O-Two Medical Technologies, Inc.
e500 Automatic Transport Ventilator, Model Number 01EVE500
Terminated
BTLK141595
Apr 25, 2017Vortran Medical Technology 1, Inc
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, con
Terminated
BTLK001430
K041473 +1
Apr 25, 2017Vortran Medical Technology 1, Inc
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure
Terminated
BTLK001430
K041473 +1
Jan 11, 2016Thornhill Research Inc
MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilator
Terminated
BTLK093261
Jan 11, 2016Thornhill Research Inc
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered tr
Terminated
BTLK093261
Oct 22, 2015Mercury Enterprises, Inc. dba Mercury Medical
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of
Terminated
BTLK093913
Apr 10, 2014Draeger Medical Systems, Inc.
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Terminated
BTLK103625
Feb 25, 2014GE Healthcare, LLC
GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on the
Terminated
BTLK070377
K090697 +2
Feb 25, 2014GE Healthcare, LLC
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resusci
Terminated
BTLK070210
Feb 3, 2014GE Healthcare
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equ
Terminated
BTLK070210
Feb 3, 2014GE Healthcare
Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M12414
Terminated
BTLK070210
Apr 16, 2013Instrumentation Industries Inc
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/I
Terminated
BTLK991785
Feb 8, 2013GE Healthcare, LLC
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic
Terminated
BTLK070210
Dec 26, 2012GE Healthcare, LLC
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece D
Terminated
BTLK070210
Nov 4, 2011Impact Instrumentation, Inc.
Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.
Terminated
BTLK051476
Jul 4, 2007Smiths Medical PM, Inc.
Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, p
Terminated
BTLK051322
Jan 24, 2006Smiths Medical PM, Inc.
Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of p
Terminated
BTLNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.