Cleared Traditional

K853083 - RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR

K853083 is an FDA 510(k) clearance for RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR, manufactured by Home Medical Supply, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K853083 · Home Medical Supply, Inc. · Anesthesiology device
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Sep 1985
Decision
42d
Days
Class 2
Risk

K853083 is an FDA 510(k) clearance for the RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Home Medical Supply, Inc. (Clearfield, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5655 - 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 - K853083

510(k) Number K853083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date September 03, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYJ Device Classification - Class 2, Special Controls

Product Code BYJ Unit, Liquid-oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5655
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 - BYJ Unit, Liquid-oxygen, Portable

All 34
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K853083.
VOYAGER PX
K895082 · Smith-Perry Corp. · Jan 1990
COMPANION LIQUID OXYGEN SYSTEM
K861503 · Puritan Bennett Corp. · Jun 1986
MARK 4 LIQUID OXYGEN SYSTEM
K860937 · Puritan Bennett Corp. · Mar 1986
LIQUID OXYGEN SYSTEM
K840534 · The John Bunn Co. · Mar 1984
INSPIRON LIQUID OXYGEN SYSTEM
K834290 · Inspiron Corp. · Feb 1984
MARK III OXYGEN WALKER SYS-LOW PRESS
K830337 · Union Carbide Corp. · Mar 1983
K853083 · RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR
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