Company ยท US
Ventlab Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2018. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
19recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 21 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 |
| BTC | Bag, Reservoir | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| BYH | Drain, Tee (Water Trap) | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| CAN | Regulator, Pressure, Gas Cylinder | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| CBH | Device, Fixation, Tracheal Tube | 1 |
| ODR | Electrosurgical Patient Return Electrode | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2018 | K173373 | SafeT T-Piece Resuscitator Ventlab, LLC | BTL |
| May 24, 2012 | K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER Ventlab Corp. | CAP |
| Jul 22, 2011 | K102674 | CUFF SENTRY Ventlab Corp. | BSK |
| Jan 27, 2011 | K093617 | VENTLAB 6000 SERIES HUMIDIFIER Ventlab Corp. | BTT |
| Dec 10, 2009 | K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE Ventlab Corp. | CCK |
| Jun 25, 2009 | K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. Ventlab Corp. | CAF |
| Aug 13, 2008 | K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD Ventlab Corp. | ODR |
| Mar 26, 2008 | K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA Ventlab Corp. | CCK |
| Jun 3, 2004 | K040726 | VENTLAB NASAL CPAP CANNULA Ventlab Corp. | BZD |
| Jul 7, 2003 | K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 Ventlab Corp. | CAH |
| Feb 11, 2002 | K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM Ventlab Corp. | NHK |
| Dec 20, 2001 | K013308 | VENTLAB HYPERINFLATION BAG SYSTEM Ventlab Corp. | NHK |
| Sep 18, 2001 | K012842 | V*CARE MANUAL RESUSCITATOR Ventlab Corp. | BTM |
| Feb 11, 1999 | K990098 | VENTLAB VERIFY II Ventlab Corp. | BTR |
| Aug 24, 1998 | K981944 | BREATHERITE Ventlab Corp. | CAF |
| Jan 7, 1992 | K913900 | V*CARE MANUAL RESUSCITATOR, CAT#VR-1000 Ventlab Corp. | BTM |
| Sep 4, 1990 | K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 Ventlab Corp. | BSJ |
| Mar 9, 1990 | K900591 | VENT-TRAP CAT# WR1000 Ventlab Corp. | BYH |
| Feb 22, 1990 | K900115 | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B Ventlab Corp. | CAN |
| Feb 2, 1990 | K900236 | ET-RESTRAINT CAT. # ER 4000 Ventlab Corp. | CBH |
| Jan 26, 1990 | K896897 | VENTLAB ANESTHESIA CIRCUIT AC 6000 Ventlab Corp. | CAI |
| Jan 9, 1990 | K896439 | TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE Ventlab Corp. | BZO |
| May 5, 1989 | K890822 | CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE) Ventlab Corp. | BZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2016 | Ventlab LLC STAT-Check Resuscitation Bag
Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer
Intended for use in various clinical situations to provide respiratory support in the presence of rever Terminated |
CCK | K093525 K982215 |
| Jul 3, 2014 | Ventlab LLC Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC81 Terminated |
BTM | K012842 K953546 +1 |
| Nov 1, 2012 | Ventlab Corporation AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028
The Disposable Resuscitators with optional built-in pressure Terminated |
BTM | K012842 |
| Nov 1, 2012 | Ventlab Corporation AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028
The Disposable Resuscitators with optional built-in pressure monito Terminated |
BTM | K012842 |
| Nov 1, 2012 | Ventlab Corporation Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
The Disposable Resuscitators with optional built-in pressure monitor is intended to Terminated |
BTM | K012842 |
| Nov 1, 2012 | Ventlab Corporation Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
The Disposable Resuscitators with optional built-in pressure monitor is intended Terminated |
BTM | K012842 |
| Nov 1, 2012 | Ventlab Corporation Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. Terminated |
BTM | K012842 |
| Nov 1, 2012 | Ventlab Corporation Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use,
The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence o Terminated |
BTM | K012842 |
| 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 20, 2008 | Ventlab Corporation Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk. Terminated |
BTC | None listed |
| 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 |
| 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 |