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)
Top companies in BTM
| Company | 510(k)s | Recalls |
|---|---|---|
| Unomedical | 0 | 23 |
| Ventlab Corp. | 2 | 19 |
| Ambu, Inc. | 15 | 1 |
| Sun Med, LLC | 0 | 14 |
| Puritan Bennett Corp. | 13 | 0 |
| Medical Marketing Concepts | 11 | 0 |
| Vyaire Medical | 0 | 11 |
| SunMed Holdings, LLC | 0 | 10 |
| Laerdal Medical AS | 3 | 4 |
| Life Design Systems, Inc. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K982215 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Sep 8, 2010 | Westmed 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 |
BTM | K934310 K940581 |
| Sep 8, 2010 | Westmed 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 |
BTM | K934310 K940581 |
| May 9, 2010 | Precision 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 |
BTM | K843223 |
| Nov 4, 2009 | Unomedical Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733 Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728 Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725 Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. foreign Distribution only:
Product number 733-E. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only.
Product code: 725-E, Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E; 86-742E.
Packaged under the name of Hospitak, McKesson. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708.
Packaged under the name of Evergreen. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707.
Packaged under the name of Evergreen. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705.
Packaged under the name of Evergreen. Terminated |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Nov 4, 2009 | Unomedical 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 |
BTM | K873286 |
| Jul 20, 2004 | Ventlab 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 |
BTM | K982215 |
| Jul 20, 2004 | Ventlab 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 |
BTM | K982215 |
| Jul 20, 2004 | Ventlab 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 |
BTM | K982215 |
| Jul 20, 2004 | Ventlab 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 |
BTM | K982215 |
| Jul 20, 2004 | Ventlab 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 |
BTM | K982215 |
| Feb 27, 2004 | Instrumentation Industries Inc BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge. Terminated |
BTM | None listed |
| Feb 27, 2004 | Instrumentation Industries Inc BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator Terminated |
BTM | K991785 |
| Feb 10, 2004 | Laerdal 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 |
BTM | None listed |
| Feb 10, 2004 | Laerdal 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 |
BTM | None listed |
| Feb 10, 2004 | Laerdal 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 |
BTM | None listed |
| Feb 10, 2004 | Laerdal 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 |
BTM | None listed |
| Jul 8, 2003 | Ventlab 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 |
BTM | None listed |
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8506P Terminated |
BTM | K014115 |
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8503P Terminated |
BTM | K014115 |
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8500P Terminated |
BTM | K014115 |
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