CAP · Class II · 21 CFR 868.2600

FDA Product Code CAP: Monitor, Airway Pressure (includes Gauge And/or Alarm)

Leading manufacturers include Draeger Medical, Inc., Vortran Medical Technology 1, Inc. and Respiratory Support Products, Inc..

78
Total
78
Cleared
106d
Avg days
1978
Since

FDA 510(k) Cleared Monitor, Airway Pressure (includes Gauge And/or Alarm) Devices (Product Code CAP)

78 devices
1–24 of 78
Cleared Nov 13, 2020
SINGLE USE MANOMETER
K201666
Flexicare Medical Limited.
Anesthesiology · 147d
Cleared Sep 18, 2019
VORTRAN APM-Plus
K182292
Vortran Medical Technology 1, Inc.
Anesthesiology · 391d
Cleared May 01, 2019
NS 120P-TRS Airway Pressure Gauge
K180510
Instrumentation Industries, Inc.
Anesthesiology · 428d
Cleared Feb 09, 2018
NAPA LP-15 Airway Pressure Monitor
K172284
Drw Medical, LLC
Anesthesiology · 196d
Cleared Sep 16, 2016
VORTRAN Manometer
K153733
Vortran Medical Technology 1, Inc.
Anesthesiology · 263d
Cleared Aug 11, 2015
Disposable Pressure Manometer (DPM)
K143148
Westmed, Inc.
Anesthesiology · 281d
Cleared Jun 19, 2014
DISPOSABLE PRESSURE MANOMETER
K140370
Besmed Health Business Corp
Anesthesiology · 125d
Cleared Aug 22, 2013
GIO DIGITAL PRESSURE GUAGES
K122627
Galemed Corp.
Anesthesiology · 359d
Cleared Jan 10, 2013
MANOMETER
K122077
Intersurgical, Inc.
Anesthesiology · 178d
Cleared May 24, 2012
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
K120118
Ventlab Corp.
Anesthesiology · 128d
Cleared Sep 15, 2011
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
K103639
Vortran Medical Technology 1, Inc.
Anesthesiology · 276d
Cleared Jun 10, 2011
PRESSURE MANOMETER
K110119
Neoforce Group, Inc.
Anesthesiology · 143d
Cleared Sep 12, 2008
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K081778
Instrumentation Industries, Inc.
Anesthesiology · 81d
Cleared Mar 25, 2005
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
K050309
Viasys Medsystems
Anesthesiology · 45d
Cleared Jul 22, 2004
AMBU DISPOSABLE PRESSURE MANOMETER
K040991
Ambu, Inc.
Anesthesiology · 97d
Cleared Aug 22, 2002
DISPOSABLE PRESSURE MANOMETER
K022402
Vital Signs, Inc.
Anesthesiology · 30d
Cleared Nov 30, 2000
DISPOSABLE PRESSURE MONITOR
K003497
Engineered Medical Systems
Anesthesiology · 17d
Cleared Jan 06, 2000
CRITERION 40 OR PM 40
K992101
Caradyne, Ltd.
Anesthesiology · 198d
Cleared Jul 23, 1998
TSX PRM PULMONARY RESUSCITATION MONITOR
K973347
Spiracle Technology
Anesthesiology · 321d
Cleared Dec 17, 1996
1ST RESPONSE DISPOSABLE MANOMETER
K961318
Intertech Resources, Inc.
Anesthesiology · 256d
Cleared Apr 25, 1996
MERCURY AIRWAY PRESSURE MANOMETER
K954486
Mercury Medical
Anesthesiology · 211d
Cleared Apr 03, 1991
RESPIRONICS' DIGITAL MANOMETER
K904935
Respironics, Inc.
Anesthesiology · 153d
Cleared Aug 17, 1990
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276
Respironics, Inc.
Anesthesiology · 88d
Cleared Jan 09, 1990
INFANT C.P.A.P. MONITOR
K896136
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 78d

About Product Code CAP - Regulatory Context