CAP · Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Anesthesiology · 21 CFR 868.2600 · Class 2
Overview
| Product Code | CAP |
|---|---|
| Device Name | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Regulation | 21 CFR 868.2600 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 78)
Showing 20 most recent of 78 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201666 | SINGLE USE MANOMETER | Flexicare Medical Limited. | Nov 13, 2020 | SESE |
| K182292 | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | Sep 18, 2019 | SESE |
| K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | May 1, 2019 | SESE |
| K172284 | NAPA LP-15 Airway Pressure Monitor | Drw Medical, LLC | Feb 9, 2018 | SESE |
| K153733 | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | Sep 16, 2016 | SESE |
| K143148 | Disposable Pressure Manometer (DPM) | Westmed, Inc. | Aug 11, 2015 | SESE |
| K140370 | DISPOSABLE PRESSURE MANOMETER | Besmed Health Business Corp | Jun 19, 2014 | SESE |
| K122627 | GIO DIGITAL PRESSURE GUAGES | Galemed Corp. | Aug 22, 2013 | SESE |
| K122077 | MANOMETER | Intersurgical, Inc. | Jan 10, 2013 | SESE |
| K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | Ventlab Corp. | May 24, 2012 | SESE |
| K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | Vortran Medical Technology 1, Inc. | Sep 15, 2011 | SESE |
| K110119 | PRESSURE MANOMETER | Neoforce Group, Inc. | Jun 10, 2011 | SESE |
| K102377 | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 | A Plus Medical | Nov 18, 2010 | SESE |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | Instrumentation Industries, Inc. | Sep 12, 2008 | SESE |
| K050309 | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | Viasys Medsystems | Mar 25, 2005 | SESE |
| K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | Ambu, Inc. | Jul 22, 2004 | SESE |
| K022402 | DISPOSABLE PRESSURE MANOMETER | Vital Signs, Inc. | Aug 22, 2002 | SESE |
| K003497 | DISPOSABLE PRESSURE MONITOR | Engineered Medical Systems | Nov 30, 2000 | SESE |
| K000959 | CRITERION 60 OR PM 60 | Caradyne, Ltd. | Jun 22, 2000 | SESE |
| K992101 | CRITERION 40 OR PM 40 | Caradyne, Ltd. | Jan 6, 2000 | SESE |
Top Applicants
- Canadian Monaghan , Ltd. — 5 clearances
- Intersect Medical Products, Inc. — 4 clearances
- Draeger Medical, Inc. — 3 clearances
- Penlon, Inc. — 3 clearances
- Vortran Medical Technology 1, Inc. — 3 clearances
