Cleared Traditional

K853139 - PHOENIX ANESTHESIA MACHINE

K853139 is an FDA 510(k) clearance for PHOENIX ANESTHESIA MACHINE, manufactured by American Anesthesia, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K853139 · American Anesthesia, Inc. · Anesthesiology device
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Aug 1985
Decision
38d
Days
Class 2
Risk

K853139 is an FDA 510(k) clearance for the PHOENIX ANESTHESIA MACHINE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by American Anesthesia, Inc. (Orange, US). The FDA issued a Cleared decision on August 26, 1985 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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.

FDA 510(k) Submission Details - K853139

510(k) Number K853139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date August 26, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 140d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 163
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K853139.
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
K861170 · Draeger Medical, Inc. · Apr 1986
NARKOMED 3 ANESTHESIA SYSTEM
K853435 · Draeger Medical, Inc. · Jan 1986
ARI STANDARD ANESTHESIA RECORD
K854213 · Agilent Technologies, Inc. · Dec 1985
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K850648 · Ohmeda Medical · Jul 1985
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · Ohmeda Medical · May 1985
BOOM ARM
K851621 · Draeger Medical, Inc. · May 1985
K853139 · PHOENIX ANESTHESIA MACHINE
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