Vortran Medical Technology 1, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 28
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2092-2017 | Class II | VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesth | April 20, 2017 |
| Z-2091-2017 | Class II | VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This devic | April 20, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K202219 | VORTRAN GO2VENT with PEEP Valve | February 11, 2021 |
| K182292 | VORTRAN APM-Plus | September 18, 2019 |
| K173914 | VORTRAN Cuff Inflator (VCI) | May 25, 2018 |
| K162968 | VORTRAN GO2VENT | April 10, 2017 |
| K153733 | VORTRAN Manometer | September 16, 2016 |
| K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | September 15, 2011 |
| K073261 | VAR MONITOR | May 23, 2008 |
| K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | July 15, 2004 |
| K003684 | PERCUSSIVENEB, MODEL PN-2001 | February 23, 2001 |
| K001430 | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 | July 5, 2000 |
| K982016 | PIPER IPPB MODEL 2055 | November 3, 1998 |
| K981726 | PERCUSSIVETECH HF, MODEL 2001 | September 17, 1998 |
| K973975 | RESPIRTECHPRO | June 12, 1998 |
| K963910 | HEART NEBULIZER #100609 | December 16, 1996 |
| K943600 | UNIHEART | October 13, 1994 |
| K944643 | AUTONEB ACCESSORY CROSS (AAC) | October 4, 1994 |
| K935693 | AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT | August 25, 1994 |
| K933915 | VENTI-GENTLE-HALER(TM) | October 28, 1993 |
| K924667 | AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY) | August 26, 1993 |
| K924649 | SOFT-MIST(TM) | May 17, 1993 |