Cleared Traditional

K920910 - OXYGEN POWERED RESUSCITATOR FOR CPR

K920910 is an FDA 510(k) clearance for OXYGEN POWERED RESUSCITATOR FOR CPR, manufactured by J. H. Emerson Co.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K920910 · J. H. Emerson Co. · Anesthesiology device
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Jan 1993
Decision
320d
Days
Class 2
Risk

K920910 is an FDA 510(k) clearance for the OXYGEN POWERED RESUSCITATOR FOR CPR. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Cambridge, US). The FDA issued a Cleared decision on January 12, 1993 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 J. H. Emerson Co. devices

FDA 510(k) Submission Details - K920910

510(k) Number K920910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date January 12, 1993
Days to Decision 320 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
180d slower than avg
Panel avg: 140d · This submission: 320d
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 K920910.
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785 · Instrumentation Industries, Inc. · Aug 1999
RESPIRTECHPRO
K973975 · Vortran Medical Technology 1, Inc. · Jun 1998
IMPACT MODEL 753
K931473 · Impact Instrumentation, Inc. · Dec 1994
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920 · Ambu, Inc. · May 1991
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697 · Impact Instrumentation, Inc. · Dec 1990
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · Ohmeda Medical · Aug 1990