Cleared Traditional

K081468 - DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES

K081468 is an FDA 510(k) clearance for DEVILBISS PORTABLE OXYGEN CONCENTRATOR, manufactured by Sunrise Medical. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K081468 · Sunrise Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
90d
Days
Class 2
Risk

K081468 is an FDA 510(k) clearance for the DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES. 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 Sunrise Medical (Somerset, US). The FDA issued a Cleared decision on August 25, 2008 after a review of 90 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K081468

510(k) Number K081468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date August 25, 2008
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K081468.
PRECISION OXYGEN CONCENTRATOR
K072348 · Precision Medical, Inc. · Oct 2008
HYGEIA-5 OXYGEN CONCENTRATOR
K081267 · Kedl Internation Limited · Sep 2008
HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
K081508 · Shenyang Canta Medical Tech. Co., Ltd. · Aug 2008
HOMELOX
K081206 · Respironics, Inc. · Jul 2008
OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS
K080082 · Oxlife, LLC · Apr 2008
DRIVE SOLSTICE OXYGEN CONCENTRATOR
K080391 · Medical Depot · Mar 2008