Cleared Traditional

K854769 - LNI MGV MEDICAL GAS MIXER

K854769 is the FDA 510(k) clearance for LNI MGV MEDICAL GAS MIXER by P.A. Mccauley, Inc.. It is a Class 2 Anesthesiology device (product code BZR) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K854769 · P.A. Mccauley, Inc. · Anesthesiology device
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Jun 1986
Decision
190d
Days
Class 2
Risk

K854769 is an FDA 510(k) clearance for the LNI MGV MEDICAL GAS MIXER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by P.A. Mccauley, Inc. (Marietta, US). The FDA issued a Cleared decision on June 5, 1986 after a review of 190 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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 P.A. Mccauley, Inc. devices

Submission Details

510(k) Number K854769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1985
Decision Date June 05, 1986
Days to Decision 190 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 140d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 13
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