Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2600](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2600) → CAP — Monitor, Airway Pressure (Includes Gauge And/Or Alarm) # CAP · Monitor, Airway Pressure (Includes Gauge And/Or Alarm) _Anesthesiology · 21 CFR 868.2600 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP ## Overview - **Product Code:** CAP - **Device Name:** Monitor, Airway Pressure (Includes Gauge And/Or Alarm) - **Regulation:** [21 CFR 868.2600](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2600) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K201666.md) | SINGLE USE MANOMETER | Flexicare Medical Limited. | Nov 13, 2020 | SESE | | [K182292](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K182292.md) | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | Sep 18, 2019 | SESE | | [K180510](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K180510.md) | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | May 1, 2019 | SESE | | [K172284](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K172284.md) | NAPA LP-15 Airway Pressure Monitor | Drw Medical, LLC | Feb 9, 2018 | SESE | | [K153733](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K153733.md) | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | Sep 16, 2016 | SESE | | [K143148](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K143148.md) | Disposable Pressure Manometer (DPM) | Westmed, Inc. | Aug 11, 2015 | SESE | | [K140370](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K140370.md) | DISPOSABLE PRESSURE MANOMETER | Besmed Health Business Corp | Jun 19, 2014 | SESE | | [K122627](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K122627.md) | GIO DIGITAL PRESSURE GUAGES | Galemed Corp. | Aug 22, 2013 | SESE | | [K122077](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K122077.md) | MANOMETER | Intersurgical, Inc. | Jan 10, 2013 | SESE | | [K120118](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K120118.md) | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | Ventlab Corp. | May 24, 2012 | SESE | | [K103639](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K103639.md) | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | Vortran Medical Technology 1, Inc. | Sep 15, 2011 | SESE | | [K110119](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K110119.md) | PRESSURE MANOMETER | Neoforce Group, Inc. | Jun 10, 2011 | SESE | | [K102377](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K102377.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K081778.md) | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | Instrumentation Industries, Inc. | Sep 12, 2008 | SESE | | [K050309](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K050309.md) | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | Viasys Medsystems | Mar 25, 2005 | SESE | | [K040991](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K040991.md) | AMBU DISPOSABLE PRESSURE MANOMETER | Ambu, Inc. | Jul 22, 2004 | SESE | | [K022402](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K022402.md) | DISPOSABLE PRESSURE MANOMETER | Vital Signs, Inc. | Aug 22, 2002 | SESE | | [K003497](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K003497.md) | DISPOSABLE PRESSURE MONITOR | Engineered Medical Systems | Nov 30, 2000 | SESE | | [K000959](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K000959.md) | CRITERION 60 OR PM 60 | Caradyne, Ltd. | Jun 22, 2000 | SESE | | [K992101](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP/K992101.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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