Cleared Traditional

K040991 - AMBU DISPOSABLE PRESSURE MANOMETER

K040991 is an FDA 510(k) clearance for AMBU DISPOSABLE PRESSURE MANOMETER, manufactured by Ambu, Inc.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K040991 · Ambu, Inc. · Anesthesiology device
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Jul 2004
Decision
97d
Days
Class 2
Risk

K040991 is an FDA 510(k) clearance for the AMBU DISPOSABLE PRESSURE MANOMETER. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on July 22, 2004 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ambu, Inc. devices

FDA 510(k) Submission Details - K040991

510(k) Number K040991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2004
Decision Date July 22, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 140d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 35
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K040991.
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
K120118 · Ventlab Corp. · May 2012
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
K103639 · Vortran Medical Technology 1, Inc. · Sep 2011
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K081778 · Instrumentation Industries, Inc. · Sep 2008
DISPOSABLE PRESSURE MANOMETER
K022402 · Vital Signs, Inc. · Aug 2002
1ST RESPONSE DISPOSABLE MANOMETER
K961318 · Intertech Resources, Inc. · Dec 1996
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991