Data / Medical devices / United States / Vortran Medical Technology 1, Inc.
Vortran Medical Technology 1, Inc.: FDA-registered device maker in Sacramento, CA, United States, 10 510(k) clearances
Vortran Medical Technology 1, Inc. is registered with the FDA (registration 2951529) in Sacramento, CA, United States. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 11, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2951529
- FEI number
- 1000307109
- Address
- 21 Goldenland Court Suite 100, Sacramento, CA, United States, 95834
- Owner or operator
- VORTRAN MEDICAL TECHNOLOGY 1, INC. (2082582)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 18, 2007
- Registered through
- 2026
- Brand names listed
- GO2VENT®, PercussiveNEB, PercussiveTech HF, Piper IPPB, VAR-Plus Model PCM/PCE, VORTRAN APM-3900 Adult Model, VORTRAN APM-Plus, VORTRAN Airway Pressure Monitor Connection Kits and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Manufacturer | accessdata.fda.gov |
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 11, 2021 | K202219 | VORTRAN GO2VENT with PEEP Valve | BTL | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| September 18, 2019 | K182292 | VORTRAN APM-Plus | CAP | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| May 25, 2018 | K173914 | VORTRAN Cuff Inflator (VCI) | BSK | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| April 10, 2017 | K162968 | VORTRAN GO2VENT | BTL | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| September 16, 2016 | K153733 | VORTRAN Manometer | CAP | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| September 15, 2011 | K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | CAP | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| November 19, 2008 | K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | BTI | Substantially Equivalent | Emg Technology Co., Ltd. | accessdata.fda.gov |
| July 15, 2004 | K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | BTL | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| February 23, 2001 | K003684 | PERCUSSIVENEB, MODEL PN-2001 | NHJ | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
| November 3, 1998 | K982016 | PIPER IPPB MODEL 2055 | NHJ | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 20, 2017 | 77072 | Class II | Terminated | 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 s | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Ventilator, Emergency, Powered (Resuscitator)
- All makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- All makers of Compressor, Air, Portable
- All makers of Device, Positive Pressure Breathing, Intermittent
Updated February 11, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.