Cleared Traditional

K842122 - 4A

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

K842122 · Life Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 122
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K842122.
MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM
K854070 · Puritan Bennett Corp. · Feb 1986
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY
K854300 · Puritan Bennett Corp. · Jan 1986
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K851509 · Ohmeda Medical · Jul 1985
MICROPROCESSOR 7200A VENTILATOR
K843424 · Puritan Bennett Corp. · Nov 1984
7200 MICROPROCESSOR VENTILATOR
K841757 · Puritan Bennett Corp. · May 1984
MICROPROCESSOR VENTILATOR 7200
K833786 · Puritan Bennett Corp. · Dec 1983