Cleared Traditional

K071581 - BACKPACK MEDICAL OXYGEN SYSTEM

K071581 is an FDA 510(k) clearance for BACKPACK MEDICAL OXYGEN SYSTEM, 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 33-day FDA review.

K071581 · Essex Cryogenics of Missouri, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
33d
Days
Class 2
Risk

K071581 is an FDA 510(k) clearance for the BACKPACK MEDICAL 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 July 11, 2007 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.

FDA 510(k) Submission Details - K071581

510(k) Number K071581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2007
Decision Date July 11, 2007
Days to Decision 33 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
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. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BYJ Unit, Liquid-oxygen, Portable

All 32
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K071581.
MODIFICATION TO: SPIRIT
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K072723 · Respironics, Inc. · Mar 2008
COPD LIQUID OXYGEN PORTABLE, MODEL 300P
K072011 · Copd Partners, Inc. · Oct 2007
SPIRIT, MODEL HAS
K050153 · Caire, Inc. · Apr 2005
PLIX
K050414 · Respironics, Inc. · Apr 2005
PRECISION LIQUID OXYGEN SYSTEM
K041122 · Precision Medical, Inc. · Oct 2004