Atlas FDA

V*CARE MANUAL RESUSCITATOR

FDA 510(k) clearance K012842 · decided 2001-09-18

Clearance details

K-number
K012842
Device name
V*CARE MANUAL RESUSCITATOR
Applicant
Ventlab Corp.
Decision
Substantially Equivalent
Date received
2001-08-23
Decision date
2001-09-18
Days to decision
26 days
Clearance type
Special
Product code
BTM
Device class
2
Regulation number
868.5915
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mocksville, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple acces recall (Z-0361-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory recall (Z-0362-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory co recall (Z-0363-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory c recall (Z-0364-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory c recall (Z-0365-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory recall (Z-0366-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory con recall (Z-0367-2024)SunMed Holdings, LLC2023-11-21
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations recall (Z-0368-2024)SunMed Holdings, LLC2023-11-21
Medline manual resuscitators with integrated manometer, multiple accessory configurations recall (Z-0369-2024)SunMed Holdings, LLC2023-11-21
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT recall (Z-1948-2014)Ventlab LLC2014-07-03
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab recall (Z-0170-2013)Ventlab Corporation2012-11-01
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with recall (Z-0171-2013)Ventlab Corporation2012-11-01
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Vent recall (Z-0173-2013)Ventlab Corporation2012-11-01
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ve recall (Z-0174-2013)Ventlab Corporation2012-11-01
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Vent recall (Z-0175-2013)Ventlab Corporation2012-11-01
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resusci recall (Z-0176-2013)Ventlab Corporation2012-11-01
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce recall (Z-0177-2013)Ventlab Corporation2012-11-01
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce recall (Z-0178-2013)Ventlab Corporation2012-11-01
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Dr recall (Z-0179-2013)Ventlab Corporation2012-11-01
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporat recall (Z-0180-2013)Ventlab Corporation2012-11-01
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Cor recall (Z-0181-2013)Ventlab Corporation2012-11-01