Cleared Traditional

K941819 - LIQUID OXYGEN STORAGE SUBSYSTEM

K941819 is an FDA 510(k) clearance for LIQUID OXYGEN STORAGE SUBSYSTEM, manufactured by Hogan & Hartson. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K941819 · Hogan & Hartson · Anesthesiology device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
40d
Days
Class 2
Risk

K941819 is an FDA 510(k) clearance for the LIQUID OXYGEN STORAGE SUBSYSTEM. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on May 23, 1994 after a review of 40 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 Hogan & Hartson devices

FDA 510(k) Submission Details - K941819

510(k) Number K941819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1994
Decision Date May 23, 1994
Days to Decision 40 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 140d · This submission: 40d
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 18
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K941819.
PLIX
K050414 · Respironics, Inc. · Apr 2005
PRECISION LIQUID OXYGEN SYSTEM
K041122 · Precision Medical, Inc. · Oct 2004
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · Puritan Bennett Corp. · Oct 1999
PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT
K933930 · Puritan Bennett Corp. · Mar 1994
MOBILAIRE LIQUID OXYGEN SYSTEMS
K926267 · Invacare Corp. · Aug 1993
PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE
K903140 · Puritan Bennett Corp. · Sep 1990