ClearanceBrief
Panels › Anesthesiology › Product code BTM · Class 2

Ventilator, Emergency, Manual (Resuscitator)

Regulation 868.5915

2510(k)s in 12 months (210 all time)
1recalls in 12 months (97 all time)
80recalls that name a 510(k)
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Top companies in BTM

DateFirm and productCodeLinked 510(k)
Nov 1, 2012Ventlab Corporation
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pre
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pr
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 270
Terminated
BTMK982215
Nov 1, 2012Ventlab Corporation
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversibl
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pres
Terminated
BTMK012842
Sep 8, 2010Westmed Inc
BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathi
Terminated
BTMK934310
K940581
Sep 8, 2010Westmed Inc
BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathi
Terminated
BTMK934310
K940581
May 9, 2010Precision Medical, Inc.
PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of
Terminated
BTMK843223
Nov 4, 2009Unomedical
Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733
Terminated
BTMK873286
Nov 4, 2009Unomedical
Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728
Terminated
BTMK873286
Nov 4, 2009Unomedical
Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725
Terminated
BTMK873286
Nov 4, 2009Unomedical
Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only: Product codes: 734-E, 734MM.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. foreign Distribution only: Product number 733-E.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only. Product code: 725-E,
Terminated
BTMK873286
Nov 4, 2009Unomedical
Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E; 86-742E. Packaged under the name of Hospitak, McKesson.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face
Terminated
BTMK873286
Nov 4, 2009Unomedical
Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & standard elbow. Product ID # 722-E, 86-722-E; 722MM. Packaged under the name of Hospitak and McKesson
Terminated
BTMK873286
Nov 4, 2009Unomedical
Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E. Packaged under the name of Evergreen, Hospitak and McKesson.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID # 12-8710, 726-E; 86-722E, 726MM. Packaged under the name of Evergreen, Hospitak, and McKesson.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergreen.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707. Packaged under the name of Evergreen.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705. Packaged under the name of Evergreen.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM.
Terminated
BTMK873286
Nov 4, 2009Unomedical
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and
Terminated
BTMK873286
Nov 4, 2009Unomedical
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and
Terminated
BTMK873286
Nov 4, 2009Unomedical
Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and H
Terminated
BTMK873286
Nov 4, 2009Unomedical
Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospita
Terminated
BTMK873286
Jul 20, 2004Ventlab Corporation
STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Seri
Terminated
BTMK982215
Jul 20, 2004Ventlab Corporation
STAT-Check Infant Disposable Manual Resuscitators, with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use Non-Sterile, Re-Order SC7000 Series, Non Latex, Ventlab Corporation
Terminated
BTMK982215
Jul 20, 2004Ventlab Corporation
A.C.E. STAT-Check CO Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscitation ACE Corp., 155 Boyce Drive, Mocksville, NC 27028
Terminated
BTMK982215
Jul 20, 2004Ventlab Corporation
STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce D
Terminated
BTMK982215
Jul 20, 2004Ventlab Corporation
STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series, Ventlab Corporation, 155 Boyce Drive
Terminated
BTMK982215
Feb 27, 2004Instrumentation Industries Inc
BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.
Terminated
BTMNone listed
Feb 27, 2004Instrumentation Industries Inc
BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator
Terminated
BTMK991785
Feb 10, 2004Laerdal Medical Corporation
Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls,
Terminated
BTMNone listed
Feb 10, 2004Laerdal Medical Corporation
LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm
Terminated
BTMNone listed
Feb 10, 2004Laerdal Medical Corporation
LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051-Pediatric Complete in Carton; 860052-St
Terminated
BTMNone listed
Feb 10, 2004Laerdal Medical Corporation
LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard wi
Terminated
BTMNone listed
Jul 8, 2003Ventlab Corporation
V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included
Terminated
BTMNone listed
May 22, 2003Sims Portex Inc.
Portex 1st Response Adult Manual Resuscitators Ref: 8506P
Terminated
BTMK014115
May 22, 2003Sims Portex Inc.
Portex 1st Response Adult Manual Resuscitators Ref: 8503P
Terminated
BTMK014115
May 22, 2003Sims Portex Inc.
Portex 1st Response Adult Manual Resuscitators Ref: 8500P
Terminated
BTMK014115

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