Cleared Traditional

K842122 - 4A

K842122 is an FDA 510(k) clearance for 4A, manufactured by Life Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K842122 · Life Products, Inc. · Anesthesiology device
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Jan 1985
Decision
234d
Days
Class 2
Risk

K842122 is an FDA 510(k) clearance for the 4A. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Life Products, Inc. (Boulder, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 234 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Life Products, Inc. devices

FDA 510(k) Submission Details - K842122

510(k) Number K842122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1984
Decision Date January 18, 1985
Days to Decision 234 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 140d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 417
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K842122.
HEALTHDYNE IMPLUSE VENTILATOR
K853300 · Healthdyne, Inc. · Aug 1985
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K851509 · Ohmeda Medical · Jul 1985
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO
K850374 · Siemens Elema AB · Apr 1985
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
K844912 · Siemens Elema AB · Dec 1984
NEWPORT VENTILATOR MODEL E-100
K844350 · Newport Medical Instruments, Inc. · Dec 1984
POWER PACK 160 SIEMENS-ELEMA AB
K844590 · Siemens Elema AB · Nov 1984