Cleared Traditional

K813453 - UNIT

K813453 is the FDA 510(k) clearance for UNIT by Pensee Medical Corp.. It is a Class 2 Anesthesiology device (product code BYJ) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K813453 · Pensee Medical Corp. · Anesthesiology device
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Jan 1982
Decision
33d
Days
Class 2
Risk

K813453 is an FDA 510(k) clearance for the UNIT, LIQUID, OXYGEN, PORTABLE. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Pensee Medical Corp. (Walker, US). The FDA issued a Cleared decision on January 12, 1982 after a review of 33 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 Pensee Medical Corp. devices

Submission Details

510(k) Number K813453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1981
Decision Date January 12, 1982
Days to Decision 33 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 140d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K813453.
MARK III OXYGEN WALKER SYS-LOW PRESS
K830337 · Union Carbide Corp. · Mar 1983
LIQUID OXYGEN SYSTEM
K830498 · Puritan Bennett Corp. · Mar 1983
MARK III OXYGEN WALKER SYSTEM
K820836 · Union Carbide Corp. · Apr 1982
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