Cleared Traditional

K844081 - LP4 VENTILATOR

K844081 is the FDA 510(k) clearance for LP4 VENTILATOR by Life Products, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K844081 · Life Products, Inc. · Anesthesiology device
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Jan 1985
Decision
89d
Days
Class 2
Risk

K844081 is an FDA 510(k) clearance for the LP4 VENTILATOR. 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 16, 1985 after a review of 89 days - a notably fast clearance 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: 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 Life Products, Inc. devices

Submission Details

510(k) Number K844081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1984
Decision Date January 16, 1985
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 140d · This submission: 89d
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 K844081.
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