Cleared Traditional

K840349 - MARK III RESUSCITATOR

K840349 is an FDA 510(k) clearance for MARK III RESUSCITATOR, manufactured by Ambu, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K840349 · Ambu, Inc. · Anesthesiology device
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Feb 1984
Decision
15d
Days
Class 2
Risk

K840349 is an FDA 510(k) clearance for the MARK III RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ambu, Inc. (Walker, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ambu, Inc. devices

FDA 510(k) Submission Details - K840349

510(k) Number K840349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date February 10, 1984
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K840349.
FLOW CONTROLLER
K843223 · Precision Medical, Inc. · Sep 1984
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
K842487 · J. H. Emerson Co. · Jul 1984
CODE BLUE MANUAL RESUSCITATOR
K831885 · Vital Signs, Inc. · Sep 1983
SC-603 TWIN VALVE
K831486 · Instrumentation Industries, Inc. · Aug 1983
BE#1000-INSTANT ON/OFF O2 VALVE
K823408 · Instrumentation Industries, Inc. · Dec 1982