Cleared Traditional

K904920 - AMBU MATIC AUTOMATIC RESUSCITATOR

K904920 is an FDA 510(k) clearance for AMBU MATIC AUTOMATIC RESUSCITATOR, manufactured by Ambu, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K904920 · Ambu, Inc. · Anesthesiology device
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May 1991
Decision
209d
Days
Class 2
Risk

K904920 is an FDA 510(k) clearance for the AMBU MATIC AUTOMATIC RESUSCITATOR. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Ambu, Inc. (Hanover, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 209 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 - K904920

510(k) Number K904920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1990
Decision Date May 28, 1991
Days to Decision 209 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 140d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 31
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K904920.
RESPIRTECHPRO
K973975 · Vortran Medical Technology 1, Inc. · Jun 1998
IMPACT MODEL 753
K931473 · Impact Instrumentation, Inc. · Dec 1994
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910 · J. H. Emerson Co. · Jan 1993
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697 · Impact Instrumentation, Inc. · Dec 1990
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · Ohmeda Medical · Aug 1990
BIVONA CARDEN INTERMITTENT JETTING DEVICE
K895946 · Bivona Medical Technologies · Jan 1990