Cleared Traditional

K820836 - MARK III OXYGEN WALKER SYSTEM

K820836 is an FDA 510(k) clearance for MARK III OXYGEN WALKER SYSTEM, manufactured by Union Carbide Corp.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K820836 · Union Carbide Corp. · Anesthesiology device
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Apr 1982
Decision
20d
Days
Class 2
Risk

K820836 is an FDA 510(k) clearance for the MARK III OXYGEN WALKER SYSTEM. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on April 15, 1982 after a review of 20 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.

View all Union Carbide Corp. devices

FDA 510(k) Submission Details - K820836

510(k) Number K820836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1982
Decision Date April 15, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 140d · This submission: 20d
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 17
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K820836.
MARK 4 LIQUID OXYGEN SYSTEM
K860937 · Puritan Bennett Corp. · Mar 1986
MARK III OXYGEN WALKER SYS-LOW PRESS
K830337 · Union Carbide Corp. · Mar 1983
LIQUID OXYGEN SYSTEM
K830498 · Puritan Bennett Corp. · Mar 1983
LINDE MARK II
K812536 · Union Carbide Corp. · Sep 1981
LINDE MARK II OXYGEN RESERV. TYPE OR-4
K810732 · Union Carbide Corp. · Mar 1981
LINDE OXYGEN WALKER SYS. MARK II-L
K791902 · Union Carbide Corp. · Oct 1979