VORTRAN APM-Plus
FDA 510(k) K182292 · Vortran Medical Technology 1, Inc.
510(k) numberK182292
Submission
- Device name
- VORTRAN APM-Plus
- Applicant
- Vortran Medical Technology 1, Inc.
Sacramento, CA, US - Received
- August 23, 2018
- Decision date
- September 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAP – Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2600
- Specialty
- Anesthesiology
Other 510(k)s with product code CAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201666 | Single Use ManometerCAP · Traditional | Flexicare Medical Limited. | 11/13/2020SE |
| K180510 | NS 120P-TRS Airway Pressure GaugeCAP · Traditional | Instrumentation Industries, Inc. | 05/01/2019SE |
| K172284 | NAPA LP-15 Airway Pressure MonitorCAP · Traditional | Drw Medical, LLC | 02/09/2018SE |
| K153733 | VORTRAN ManometerCAP · Traditional | Vortran Medical Technology 1, Inc. | 09/16/2016SE |
| K143148 | Disposable Pressure Manometer (DPM)CAP · Traditional | Westmed, Inc. | 08/11/2015SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | Besmed Health Business Corp | 06/19/2014SE |
| K122627 | Gio Digital Pressure GuagesCAP · Traditional | Galemed Corp. | 08/22/2013SE |
| K122077 | ManometerCAP · Traditional | Intersurgical, Inc. | 01/10/2013SE |
| K120118 | Ventlab Pressurechek Disosable Column ManometerCAP · Traditional | Ventlab Corp. | 05/24/2012SE |
| K103639 | Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…CAP · Traditional | Vortran Medical Technology 1, Inc. | 09/15/2011SE |
More from Vortran Medical Technology 1, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | 02/11/2021SE |
| K173914 | VORTRAN Cuff Inflator (VCI)BSK · Traditional | 05/25/2018SE |
| K162968 | Vortran GO2VENTBTL · Traditional | 04/10/2017SE |
| K153733 | VORTRAN ManometerCAP · Traditional | 09/16/2016SE |
| K103639 | Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…CAP · Traditional | 09/15/2011SE |
| K073261 | Var MonitorBTL · Special | 05/23/2008SE |
| K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCMBTL · Traditional | 07/15/2004SE |
| K003684 | Percussiveneb, Model PN-2001NHJ · Special | 02/23/2001SE |
| K001430 | Respirtech PRO-O2C, Model 2200 and Respirtech Pro, Model 2000BTL · Traditional | 07/05/2000SE |
| K982016 | Piper Ippb Model 2055NHJ · Traditional | 11/03/1998SE |
Questions and answers
When was VORTRAN APM-Plus cleared by the FDA?
VORTRAN APM-Plus (K182292) received a 510(k) decision of Substantially Equivalent on September 18, 2019, 391 days after the submission was received.
What is the product code of K182292?
The FDA product code is CAP – Monitor, Airway Pressure (Includes Gauge And/Or Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.2600.