Product code CAP
- Device name
- Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2600
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N83074S004 | NON-ABSORBABLE BLACK SILK SUTURE | Look, Inc. | 1990-09-12 |
| N83074S002 | NON-ABSORBABLE BLACK SILK SUTURE | Look, Inc. | 1986-06-09 |
| N83074S001 | NON-ABSORBABLE BLACK SILK SUTURE | Look, Inc. | 1985-03-22 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201666 | SINGLE USE MANOMETER | Flexicare Medical Limited. | 2020-11-13 |
| K182292 | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | 2019-09-18 |
| K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | 2019-05-01 |
| K172284 | NAPA LP-15 Airway Pressure Monitor | Drw Medical, LLC | 2018-02-09 |
| K153733 | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | 2016-09-16 |
| K143148 | Disposable Pressure Manometer (DPM) | Westmed, Inc. | 2015-08-11 |
| K140370 | DISPOSABLE PRESSURE MANOMETER | Besmed Health Business Corp | 2014-06-19 |
| K122627 | GIO DIGITAL PRESSURE GUAGES | Galemed Corp. | 2013-08-22 |
| K122077 | MANOMETER | Intersurgical, Inc. | 2013-01-10 |
| K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | Ventlab Corp. | 2012-05-24 |
| K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | Vortran Medical Technology 1, Inc. | 2011-09-15 |
| K110119 | PRESSURE MANOMETER | Neoforce Group, Inc. | 2011-06-10 |
| K102377 | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 | A Plus Medical | 2010-11-18 |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | Instrumentation Industries, Inc. | 2008-09-12 |
| K050309 | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | Viasys Medsystems | 2005-03-25 |
| K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | Ambu, Inc. | 2004-07-22 |
| K022402 | DISPOSABLE PRESSURE MANOMETER | Vital Signs, Inc. | 2002-08-22 |
| K003497 | DISPOSABLE PRESSURE MONITOR | Engineered Medical Systems | 2000-11-30 |
| K000959 | CRITERION 60 OR PM 60 | Caradyne, Ltd. | 2000-06-22 |
| K992101 | CRITERION 40 OR PM 40 | Caradyne, Ltd. | 2000-01-06 |
| K973347 | TSX PRM PULMONARY RESUSCITATION MONITOR | Spiracle Technology | 1998-07-23 |
| K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | Intertech Resources, Inc. | 1996-12-17 |
| K954486 | MERCURY AIRWAY PRESSURE MANOMETER | Mercury Medical | 1996-04-25 |
| K936009 | AMS 3000M | Acutronic Medical Systems AG | 1995-05-03 |
| K943146 | PORTA-RESP MONITOR | S & M Instrument Co. | 1994-11-28 |
| K940375 | MICRO MPM | Micro Direct, Inc. | 1994-11-21 |
| K931287 | CM7000 REMOTE INDICATOR | Canadian Monaghan , Ltd. | 1993-07-01 |
| K931394 | CM5000R REMOTE INDICATOR | Canadian Monaghan , Ltd. | 1993-07-01 |
| K925673 | AIRWAY PRESSURE MONITOR CM 5000 NGAN | Canadian Monaghan , Ltd. | 1993-06-09 |
| K921978 | BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE | Core-M, Inc. | 1992-11-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889483587515 | AirLife™ | AIRLIFE | 2025-03-13 |
| 10889483587508 | AirLife™ | AIRLIFE | 2025-03-13 |
| 10351688426352 | Portex | ICU MEDICAL, INC. | 2021-02-23 |
| M996NS120PTRS0 | NS 120P-TRS Airway Pressure Monitor | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2019-06-15 |
| 10641043553596 | Manometer | MERCURY ENTERPRISES, INC. | 2018-04-15 |
| 10641043553794 | Manometer | MERCURY ENTERPRISES, INC. | 2018-04-15 |
| 10641043553787 | Manometer | MERCURY ENTERPRISES, INC. | 2018-04-15 |
| 10637320060307 | VORTRAN MANOMETER | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-10-31 |
| 10637320060314 | VORTRAN MANOMETER | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-10-31 |
| M996BE1485350 | BE 148-5-3.5 Gauge Clamp | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-09-23 |
| M996BE1485250 | BE 148-5-2.5 Gauge Clamp | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-09-23 |
| M996BE148520 | BE 148-5-2 Gauge Clamp | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-09-23 |
| M996BE148510 | BE 148-5-1 Gauge Clamp | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-09-23 |
| 10852244007362 | KENOREX | KENTRON HEALTHCARE, INC. | 2016-09-15 |
| M996NS120TRS0 | NS 120-TRS Airway Pressure Monitor | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-06-15 |
| 10637320039006 | VORTRAN Airway Pressure Monitor | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-06-14 |
| M996BE14840 | Cuff Pressure Monitor Adapter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-05-31 |
| 10641043553770 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553817 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553824 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553640 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553572 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553565 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553541 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553534 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553527 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553510 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553503 | Manometer | MERCURY ENTERPRISES, INC. | 2016-05-06 |
| 10641043553671 | Manometer | MERCURY ENTERPRISES, INC. | 2016-03-03 |
| 10641043553657 | Manometer | MERCURY ENTERPRISES, INC. | 2016-03-03 |