Company ยท US
Vortran Medical Technology 1, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2021. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 12 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 8 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 3 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 3 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 3 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2021 | K202219 | VORTRAN GO2VENT with PEEP Valve Vortran Medical Technology 1, Inc. | BTL |
| Sep 18, 2019 | K182292 | VORTRAN APM-Plus Vortran Medical Technology 1, Inc. | CAP |
| May 25, 2018 | K173914 | VORTRAN Cuff Inflator (VCI) Vortran Medical Technology 1, Inc. | BSK |
| Apr 10, 2017 | K162968 | VORTRAN GO2VENT Vortran Medical Technology 1, Inc. | BTL |
| Sep 16, 2016 | K153733 | VORTRAN Manometer Vortran Medical Technology 1, Inc. | CAP |
| Sep 15, 2011 | K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC Vortran Medical Technology 1, Inc. | CAP |
| May 23, 2008 | K073261 | VAR MONITOR Vortran Medical Technology 1, Inc. | BTL |
| Jul 15, 2004 | K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM Vortran Medical Technology 1, Inc. | BTL |
| Feb 23, 2001 | K003684 | PERCUSSIVENEB, MODEL PN-2001 Vortran Medical Technology 1, Inc. | NHJ |
| Jul 5, 2000 | K001430 | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 Vortran Medical Technology 1, Inc. | BTL |
| Nov 3, 1998 | K982016 | PIPER IPPB MODEL 2055 Vortran Medical Technology 1, Inc. | NHJ |
| Sep 17, 1998 | K981726 | PERCUSSIVETECH HF, MODEL 2001 Vortran Medical Technology 1, Inc. | NHJ |
| Jun 12, 1998 | K973975 | RESPIRTECHPRO Vortran Medical Technology 1, Inc. | BTL |
| Dec 16, 1996 | K963910 | HEART NEBULIZER #100609 Vortran Medical Technology 1, Inc. | CAF |
| Oct 13, 1994 | K943600 | UNIHEART Vortran Medical Technology 1, Inc. | CAF |
| Oct 4, 1994 | K944643 | AUTONEB ACCESSORY CROSS (AAC) Vortran Medical Technology 1, Inc. | CAF |
| Aug 25, 1994 | K935693 | AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT Vortran Medical Technology 1, Inc. | CAF |
| Oct 28, 1993 | K933915 | VENTI-GENTLE-HALER(TM) Vortran Medical Technology 1, Inc. | CAF |
| Aug 26, 1993 | K924667 | AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY) Vortran Medical Technology 1, Inc. | CAF |
| May 17, 1993 | K924649 | SOFT-MIST(TM) Vortran Medical Technology 1, Inc. | CAF |
| Oct 15, 1992 | K923596 | HEART NEBULIZER Vortran Medical Technology 1, Inc. | CAF |
| Jul 2, 1992 | K920443 | MININEB Vortran Medical Technology 1, Inc. | CAF |
| May 26, 1992 | K920332 | HEART NUBULIZER Vortran Medical Technology 1, Inc. | CAF |
| Sep 10, 1991 | K911759 | VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER Vortran Medical Technology 1, Inc. | CAF |
| Feb 12, 1990 | K896696 | (HEART) NEBULIZER Vortran Medical Technology 1, Inc. | CAF |
| Oct 9, 1987 | K873477 | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) Vortran Medical Technology 1, Inc. | CCQ |
| Aug 7, 1984 | K842988 | VMT GENTLE-HALER Vortran Medical Technology 1, Inc. | CCQ |
| Jun 5, 1984 | K841894 | VMT HAND HELD NEBULIZER Vortran Medical Technology 1, Inc. | CCQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2017 | Vortran Medical Technology 1, Inc VORTRAN Automatic Resuscitator, VARPlus with Extension Kit;
Model PCE-5012; Qty: 10 each.
Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, con Terminated |
BTL | K001430 K041473 +1 |
| Apr 25, 2017 | Vortran Medical Technology 1, Inc VORTRAN Automatic Resuscitator, VARPlus;
Model PTE-5002; Qty: 10 each
Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure Terminated |
BTL | K001430 K041473 +1 |