Ventlab LLC
FDA Regulatory Profile
Ventlab LLC appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 23 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1880-2016, Class II) was initiated on March 15, 2016. Its most recent 510(k) clearance was granted on November 16, 2018.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 23
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1880-2016 | Class II | STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer I | March 15, 2016 |
| Z-1948-2014 | Class I | Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT50 | May 16, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173373 | SafeT T-Piece Resuscitator | November 16, 2018 |
| K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | May 24, 2012 |
| K102674 | CUFF SENTRY | July 22, 2011 |
| K093617 | VENTLAB 6000 SERIES HUMIDIFIER | January 27, 2011 |
| K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITA | December 10, 2009 |
| K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. | June 25, 2009 |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | August 13, 2008 |
| K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | March 26, 2008 |
| K040726 | VENTLAB NASAL CPAP CANNULA | June 3, 2004 |
| K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 | July 7, 2003 |
| K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | February 11, 2002 |
| K013308 | VENTLAB HYPERINFLATION BAG SYSTEM | December 20, 2001 |
| K012842 | V*CARE MANUAL RESUSCITATOR | September 18, 2001 |
| K990098 | VENTLAB VERIFY II | February 11, 1999 |
| K981944 | BREATHERITE | August 24, 1998 |
| K913900 | V*CARE MANUAL RESUSCITATOR, CAT#VR-1000 | January 7, 1992 |
| K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 | September 4, 1990 |
| K900591 | VENT-TRAP CAT# WR1000 | March 9, 1990 |
| K900115 | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B | February 22, 1990 |
| K900236 | ET-RESTRAINT CAT. # ER 4000 | February 2, 1990 |