Cleared Traditional

K982722 - AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

K982722 is an FDA 510(k) clearance for AMBU MEDIBAG ADULT, manufactured by Ambu, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K982722 · Ambu, Inc. · Anesthesiology device
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Apr 1999
Decision
250d
Days
Class 2
Risk

K982722 is an FDA 510(k) clearance for the AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on April 12, 1999 after a review of 250 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 - K982722

510(k) Number K982722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1998
Decision Date April 12, 1999
Days to Decision 250 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
110d slower than avg
Panel avg: 140d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 408
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K982722.
RITEFLO SPACER
K984085 · Aeromax Technologies, Inc. · Aug 1999
SIDESTREAM NEBULIZER
K991725 · Inspired Medical Products , Ltd. · Jul 1999
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
K990384 · Piper Medical Products · Apr 1999
MDILOG, MODEL MDC-512
K990185 · Medtrak Technologies, Inc. · Apr 1999
MABIS NB-02 ULTRASONIC NEBULIZER
K990506 · Mabis Healthcare, Inc. · Mar 1999
TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER
K982181 · Trudell Medical · Jan 1999