Product Code: CAP FDA class 2 21 CFR 868.2600

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Anesthesiology

The Airway Pressure Monitor, which may include both a gauge and an alarm, is an anesthesiology device that continuously measures and displays the pressure within a patient's breathing circuit during mechanical ventilation or anesthesia, alerting clinicians to unsafe pressure levels. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAP, regulated under 21 CFR 868.2600, within the Anesthesiology medical specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: CAP
Device Class: FDA class 2
Regulation Number: 868.2600
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 78 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201666	SINGLE USE MANOMETER	Nov 13, 2020	Substantially Equivalent	Flexicare Medical Limited.
K182292	VORTRAN APM-Plus	Sep 18, 2019	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K180510	NS 120P-TRS Airway Pressure Gauge	May 01, 2019	Substantially Equivalent	Instrumentation Industries, Inc.
K172284	NAPA LP-15 Airway Pressure Monitor	Feb 09, 2018	Substantially Equivalent	Drw Medical, LLC
K153733	VORTRAN Manometer	Sep 16, 2016	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K143148	Disposable Pressure Manometer (DPM)	Aug 11, 2015	Substantially Equivalent	Westmed, Inc.
K140370	DISPOSABLE PRESSURE MANOMETER	Jun 19, 2014	Substantially Equivalent	Besmed Health Business Corp
K122627	GIO DIGITAL PRESSURE GUAGES	Aug 22, 2013	Substantially Equivalent	Galemed Corp.
K122077	MANOMETER	Jan 10, 2013	Substantially Equivalent	Intersurgical, Inc.
K120118	VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER	May 24, 2012	Substantially Equivalent	Ventlab Corp.
K103639	VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC	Sep 15, 2011	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K110119	PRESSURE MANOMETER	Jun 10, 2011	Substantially Equivalent	Neoforce Group, Inc.
K102377	VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0	Nov 18, 2010	Substantially Equivalent	A Plus Medical
K081778	NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS	Sep 12, 2008	Substantially Equivalent	Instrumentation Industries, Inc.
K050309	PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000	Mar 25, 2005	Substantially Equivalent	Viasys Medsystems
K040991	AMBU DISPOSABLE PRESSURE MANOMETER	Jul 22, 2004	Substantially Equivalent	Ambu, Inc.
K022402	DISPOSABLE PRESSURE MANOMETER	Aug 22, 2002	Substantially Equivalent	Vital Signs, Inc.
K003497	DISPOSABLE PRESSURE MONITOR	Nov 30, 2000	Substantially Equivalent	Engineered Medical Systems
K000959	CRITERION 60 OR PM 60	Jun 22, 2000	Substantially Equivalent	Caradyne, Ltd.
K992101	CRITERION 40 OR PM 40	Jan 06, 2000	Substantially Equivalent	Caradyne, Ltd.
K973347	TSX PRM PULMONARY RESUSCITATION MONITOR	Jul 23, 1998	Substantially Equivalent	Spiracle Technology
K961318	1ST RESPONSE DISPOSABLE MANOMETER	Dec 17, 1996	Substantially Equivalent	Intertech Resources, Inc.
K954486	MERCURY AIRWAY PRESSURE MANOMETER	Apr 25, 1996	Substantially Equivalent	Mercury Medical
K936009	AMS 3000M	May 03, 1995	Substantially Equivalent	Acutronic Medical Systems AG
K943146	PORTA-RESP MONITOR	Nov 28, 1994	Substantially Equivalent	S & M Instrument Co.
K940375	MICRO MPM	Nov 21, 1994	Substantially Equivalent	Micro Direct, Inc.
K931394	CM5000R REMOTE INDICATOR	Jul 01, 1993	Substantially Equivalent	Canadian Monaghan , Ltd.
K931287	CM7000 REMOTE INDICATOR	Jul 01, 1993	Substantially Equivalent	Canadian Monaghan , Ltd.
K925673	AIRWAY PRESSURE MONITOR CM 5000 NGAN	Jun 09, 1993	Substantially Equivalent	Canadian Monaghan , Ltd.
K921978	BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE	Nov 17, 1992	Substantially Equivalent	Core-M, Inc.
K904935	RESPIRONICS' DIGITAL MANOMETER	Apr 03, 1991	Substantially Equivalent	Respironics, Inc.
K902381	PENLON BREATHING SYSTEM PRESSURE MONITOR	Aug 17, 1990	Substantially Equivalent	Penlon, Inc.
K902276	RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)	Aug 17, 1990	Substantially Equivalent	Respironics, Inc.
K896136	INFANT C.P.A.P. MONITOR	Jan 09, 1990	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K895747	VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR	Oct 27, 1989	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K894361	LIFECARE PRESSURE ALARM CAT. NO. 34-010	Oct 05, 1989	Substantially Equivalent	Lifecare Services, Inc.
K894689	PENLON IDP PRESSURE FAILURE ALARM	Aug 10, 1989	Substantially Equivalent	Penlon, Inc.
K892942	BREATH TRACKER	Jun 23, 1989	Substantially Equivalent	Core-M, Inc.
K890010	CM 7000MR	Jun 12, 1989	Substantially Equivalent	Trudell Medical
K873953	CM 5000R REMOTE AIRWAY PRESSURE	Oct 27, 1987	Substantially Equivalent	Canadian Monaghan , Ltd.
K871336	M-1 PRESSURE MONITOR	Jun 05, 1987	Substantially Equivalent	Bio-Med Devices, Inc.
K871139	M-10 VENTILATION MONITOR	Apr 21, 1987	Substantially Equivalent	Bio-Med Devices, Inc.
K871083	CM 5000 MONITOR AIRWAY PRESSURE	Apr 08, 1987	Substantially Equivalent	Canadian Monaghan , Ltd.
K864536	OHMEDA 5500 AIRWAY PRESSURE MONITOR	Jan 12, 1987	Substantially Equivalent	Ohmeda Medical
K861720	MODIFIED BAROMED BREATHING PRESSURE MONITOR	May 09, 1986	Substantially Equivalent	Draeger Medical, Inc.
K861330	SECHRIST AIRWAY PRESSURE MONITOR MODEL 600	Apr 11, 1986	Substantially Equivalent	Sechrist Industries, Inc.
K854934	VENTILATOR PRESSURE ALARM MODEL VPA-100	Dec 24, 1985	Substantially Equivalent	Respiratory Support Products, Inc.
K852826	AN PRESSURE MONITOR	Dec 03, 1985	Substantially Equivalent	Ferguson Medical
K852824	PMA PRESSURE MONITOR	Dec 03, 1985	Substantially Equivalent	Ferguson Medical
K851905	LPA-2 REMOTE ALARM	Jul 08, 1985	Substantially Equivalent	Life Products, Inc.
K840420	AIRWAY PRESSURE MONITOR	Apr 05, 1984	Substantially Equivalent	Respiratory Support Products, Inc.
K840279	DRAGER BAROMED	Mar 02, 1984	Substantially Equivalent	Draeger Medical, Inc.
K832271	EMERSON MODEL 3MV-AP AND 3V-AP PRESS-	Sep 12, 1983	Substantially Equivalent	J. H. Emerson Co.
K821649	MONAGHAN'S PRESSURE ALARM	Aug 05, 1982	Substantially Equivalent	Monaghan Medical Corp.
K821667	SINGLE USE NON-CONDUCTIVE CIRC. DISCON	Jun 24, 1982	Substantially Equivalent	Vital Signs, Inc.
K820720	RESPIRATOR MONITOR	Apr 26, 1982	Substantially Equivalent	Rv Systems
K820353	MONITRON MODEL JL-7	Mar 12, 1982	Substantially Equivalent	Florida Medical Equipment Repair, Inc.
K812960	EAST VENTILARM PRESSURE MONITOR ALARM S.	Nov 16, 1981	Substantially Equivalent	Cairco , Ltd.
K812041	VENTI-MONITOR MODEL 101	Sep 25, 1981	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K812140	BIRD MEAN AIRWAY PRESSURE MONITOR	Aug 20, 1981	Substantially Equivalent	3M Company
K810753	AIRWAY PRESSURE MONITOR	Mar 31, 1981	Substantially Equivalent	Impact Instrumentation, Inc.
K810648	SECHRIST AIRWAY PRESSURE MONITOR #400	Mar 20, 1981	Substantially Equivalent	Sechrist Industries, Inc.
K810547	BLSI VENTILATION MONITOR	Mar 11, 1981	Substantially Equivalent	Bunnell Life Systems, Inc.
K810255	MEAN PRESSURE MONITOR	Feb 12, 1981	Substantially Equivalent	Healthdyne, Inc.
K802955	MONITOR, AIRWAY PRESSURE	Dec 19, 1980	Substantially Equivalent	Novametrix Medical Systems, Inc.
K802054	TRAVENOL ULTRASONIC NEBULIZER CUPS	Dec 01, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K802565	3MP-7 SCANNER RESPIRATORY MONITOR	Oct 31, 1980	Substantially Equivalent	Bird Products Corp.
K802090	DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC	Sep 26, 1980	Substantially Equivalent	Draeger Medical, Inc.
K801254	PENLON I.D.P. PRESSSURE FAILURE ALARM	Jun 09, 1980	Substantially Equivalent	Penlon, Inc.
K792516	RESPIRATOR DISCONNECT ALARM CR 201	Jan 09, 1980	Substantially Equivalent	Intersect Medical Products, Inc.
K792515	RESPIRATOR DISCONNECT ALARM	Jan 09, 1980	Substantially Equivalent	Intersect Medical Products, Inc.
K791561	RESPIRATOR DISCONNECT ALARM VA-100	Sep 19, 1979	Substantially Equivalent	Intersect Medical Products, Inc.
K791527	RESPIRATOR DISCONNECT ALARM CR201	Sep 19, 1979	Substantially Equivalent	Intersect Medical Products, Inc.
K790370	BUNN MODEL #40 LOW PRESSURE ALARM	Mar 28, 1979	Substantially Equivalent	The John Bunn Co.
K782174	PRESSURE ALARM	Jan 22, 1979	Substantially Equivalent	Thompson Respiration Products, Inc.
K781714	PNEUMOGARD MODEL 1230	Nov 27, 1978	Substantially Equivalent	Novametrix Medical Systems, Inc.
K781697	PRESSURE, LOW/HIGH MODEL C1070	Oct 27, 1978	Substantially Equivalent	Timeter Instrument Corp.
K780863	MODEL 65 HIGH & LOW PRESSURE ALARM	Aug 21, 1978	Substantially Equivalent	The John Bunn Co.