Vortran Medical Technology 1, Inc
Sacramento, CA, US
VORTRAN MEDICAL TECHNOLOGY 1, INC. appears in FDA device records in Sacramento, CA. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Vortran Medical Technology 1, Inc between 1984 and 2021. The busiest year on record is 1992, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1987 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 3 |
| 1994 | 3 |
| 1996 | 1 |
| 1998 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2004 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202219 | VORTRAN GO2VENT with PEEP Valve | BTL | Substantially Equivalent | |
| K182292 | VORTRAN APM-Plus | CAP | Substantially Equivalent | |
| K173914 | VORTRAN Cuff Inflator (VCI) | BSK | Substantially Equivalent | |
| K162968 | VORTRAN GO2VENT | BTL | Substantially Equivalent | |
| K153733 | VORTRAN Manometer | CAP | Substantially Equivalent | |
| K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | CAP | Substantially Equivalent | |
| K073261 | VAR MONITOR | BTL | Substantially Equivalent | |
| K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | BTL | Substantially Equivalent | |
| K003684 | PERCUSSIVENEB, MODEL PN-2001 | NHJ | Substantially Equivalent | |
| K001430 | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 | BTL | Substantially Equivalent | |
| K982016 | PIPER IPPB MODEL 2055 | NHJ | Substantially Equivalent | |
| K981726 | PERCUSSIVETECH HF, MODEL 2001 | NHJ | Substantially Equivalent | |
| K973975 | RESPIRTECHPRO | BTL | Substantially Equivalent | |
| K963910 | HEART NEBULIZER #100609 | CAF | Substantially Equivalent | |
| K943600 | UNIHEART | CAF | Substantially Equivalent | |
| K944643 | AUTONEB ACCESSORY CROSS (AAC) | CAF | Substantially Equivalent | |
| K935693 | AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT | CAF | Substantially Equivalent | |
| K933915 | VENTI-GENTLE-HALER(TM) | CAF | Substantially Equivalent | |
| K924667 | AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY) | CAF | Substantially Equivalent | |
| K924649 | SOFT-MIST(TM) | CAF | Substantially Equivalent | |
| K923596 | HEART NEBULIZER | CAF | Substantially Equivalent | |
| K920443 | MININEB | CAF | Substantially Equivalent | |
| K920332 | HEART NUBULIZER | CAF | Substantially Equivalent | |
| K911759 | VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER | CAF | Substantially Equivalent | |
| K896696 | (HEART) NEBULIZER | CAF | Substantially Equivalent | |
| K873477 | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) | CCQ | Substantially Equivalent | |
| K842988 | VMT GENTLE-HALER | CCQ | Substantially Equivalent | |
| K841894 | VMT HAND HELD NEBULIZER | CCQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2951529 | 1000307109 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | 21 Goldenland Court, SACRAMENTO, CA 95834 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BTICompressor, Air, Portable
- BSKCuff, Tracheal Tube, Inflatable
- NHJDevice, Positive Pressure Breathing, Intermittent
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- BTLVentilator, Emergency, Powered (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2092-2017 | 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, constant flow, pressure cycled ventilatory support. | Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction. | Class II | Terminated | |
| Z-2091-2017 | 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 cycled ventilatory support. | Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain