Cleared Traditional Expedited

K033000 - NEXT GENERATION PORTABLE THERAPEUTIC LI...

K033000 is an FDA 510(k) clearance for NEXT GENERATION PORTABLE THERAPEUTIC LI..., manufactured by Essex Cryogenics of Missouri, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K033000 · Essex Cryogenics of Missouri, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
179d
Days
Class 2
Risk

K033000 is an FDA 510(k) clearance for the NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Essex Cryogenics of Missouri, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Essex Cryogenics of Missouri, Inc. devices

FDA 510(k) Submission Details - K033000

510(k) Number K033000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2003
Decision Date March 22, 2004
Days to Decision 179 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
39d slower than avg
Panel avg: 140d · This submission: 179d
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 21
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K033000.
RESPIRONICS GOLOX
K072723 · Respironics, Inc. · Mar 2008
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
LIQUID OXYGEN STORAGE SUBSYSTEM
K941819 · Hogan & Hartson · May 1994
PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT
K933930 · Puritan Bennett Corp. · Mar 1994