Cleared Traditional

K043615 - OXYTEC, MODEL 900

K043615 is an FDA 510(k) clearance for OXYTEC, manufactured by Oxytec Medical Corporation. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K043615 · Oxytec Medical Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
41d
Days
Class 2
Risk

K043615 is an FDA 510(k) clearance for the OXYTEC, MODEL 900. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Oxytec Medical Corporation (Mccordsville, US). The FDA issued a Cleared decision on February 9, 2005 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 - K043615

510(k) Number K043615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2004
Decision Date February 09, 2005
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 224
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K043615.
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR
K050430 · Merits Health Products Co., Ltd. · Aug 2005
HOME-AWAY SYSTEM, MODEL 1041
K042944 · In-X Corporation · Apr 2005
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005
INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
K042262 · Sequal Technologies, Inc. · Sep 2004
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
K041664 · On Site Gas Systems, Inc. · Jul 2004
INOGEN ONE OXYGEN CONCENTRATOR
K032818 · Inogen, Inc. · May 2004