Cleared Traditional

K854769 - LNI MGV MEDICAL GAS MIXER

K854769 is an FDA 510(k) clearance for LNI MGV MEDICAL GAS MIXER, manufactured by P.A. Mccauley, Inc.. The device is a Class 2 Anesthesiology device with 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.

FDA 510(k) Submission Details - K854769

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.

BZR Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K854769.
BIRD MICROBLENDER M.R.I.
K895695 · Bird Products Corp. · Jul 1990
P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
K883038 · Bird Products Corp. · Nov 1988
SIEMENS O2-AIR MIXER 965
K872278 · Siemens Elema AB · Sep 1987
THE M100 AIR/OXYGEN MIXER
K860373 · Newport Medical Instruments, Inc. · May 1986
OHMEDA OXYGEN BLENDER
K853905 · Ohmeda Medical · Oct 1985
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
K841789 · Shiley, Inc. · Jul 1984
K854769 · LNI MGV MEDICAL GAS MIXER
Download PDF P.A. Mccauley, Inc.