CAP — Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Class II
FDA product code CAP covers "Monitor, Airway Pressure (Includes Gauge And/Or Alarm)", a Class II medical device regulated under 21 CFR 868.2600. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CAP
- Device Class
- Class II
- Regulation Number
- 868.2600
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201666 | flexicare medical limited | SINGLE USE MANOMETER | November 13, 2020 |
| K182292 | vortran medical technology 1 | VORTRAN APM-Plus | September 18, 2019 |
| K180510 | instrumentation industries | NS 120P-TRS Airway Pressure Gauge | May 1, 2019 |
| K172284 | drw medical | NAPA LP-15 Airway Pressure Monitor | February 9, 2018 |
| K153733 | vortran medical technology 1 | VORTRAN Manometer | September 16, 2016 |
| K143148 | westmed | Disposable Pressure Manometer (DPM) | August 11, 2015 |
| K140370 | besmed health business | DISPOSABLE PRESSURE MANOMETER | June 19, 2014 |
| K122627 | galemed | GIO DIGITAL PRESSURE GUAGES | August 22, 2013 |
| K122077 | intersurgical | MANOMETER | January 10, 2013 |
| K120118 | ventlab | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | May 24, 2012 |
| K103639 | vortran medical technology 1 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V | September 15, 2011 |
| K110119 | neoforce group | PRESSURE MANOMETER | June 10, 2011 |
| K102377 | a plus medical | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 | November 18, 2010 |
| K081778 | instrumentation industries | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | September 12, 2008 |
| K050309 | viasys medsystems | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | March 25, 2005 |
| K040991 | ambu | AMBU DISPOSABLE PRESSURE MANOMETER | July 22, 2004 |
| K022402 | vital signs | DISPOSABLE PRESSURE MANOMETER | August 22, 2002 |
| K003497 | engineered medical systems | DISPOSABLE PRESSURE MONITOR | November 30, 2000 |
| K000959 | caradyne | CRITERION 60 OR PM 60 | June 22, 2000 |
| K992101 | caradyne | CRITERION 40 OR PM 40 | January 6, 2000 |