Ventlab LLC

FDA Regulatory Profile

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1880-2016Class IISTAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer IMarch 15, 2016
Z-1948-2014Class IManual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT50May 16, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K173373SafeT T-Piece ResuscitatorNovember 16, 2018
K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERMay 24, 2012
K102674CUFF SENTRYJuly 22, 2011
K093617VENTLAB 6000 SERIES HUMIDIFIERJanuary 27, 2011
K093525ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITADecember 10, 2009
K090840VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.June 25, 2009
K082204SERIES SY DISPOSABLE ELECTROSURGICAL PADAugust 13, 2008
K063813VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULAMarch 26, 2008
K040726VENTLAB NASAL CPAP CANNULAJune 3, 2004
K030271VENTLAB BACTERIAL FILTER, MODEL BF100July 7, 2003
K020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMFebruary 11, 2002
K013308VENTLAB HYPERINFLATION BAG SYSTEMDecember 20, 2001
K012842V*CARE MANUAL RESUSCITATORSeptember 18, 2001
K990098VENTLAB VERIFY IIFebruary 11, 1999
K981944BREATHERITEAugust 24, 1998
K913900V*CARE MANUAL RESUSCITATOR, CAT#VR-1000January 7, 1992
K903881VENTLAB VENT-MASK, CAT# VR 0010/20/30September 4, 1990
K900591VENT-TRAP CAT# WR1000March 9, 1990
K900115VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 BFebruary 22, 1990
K900236ET-RESTRAINT CAT. # ER 4000February 2, 1990