Cleared Traditional

K080391 - DRIVE SOLSTICE OXYGEN CONCENTRATOR

K080391 is an FDA 510(k) clearance for DRIVE SOLSTICE OXYGEN CONCENTRATOR, manufactured by Medical Depot. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K080391 · Medical Depot · Anesthesiology device
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Mar 2008
Decision
34d
Days
Class 2
Risk

K080391 is an FDA 510(k) clearance for the DRIVE SOLSTICE OXYGEN CONCENTRATOR. 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 Medical Depot (Appollo Beach, US). The FDA issued a Cleared decision on March 18, 2008 after a review of 34 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.

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FDA 510(k) Submission Details - K080391

510(k) Number K080391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date March 18, 2008
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 121
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K080391.
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751 · Invacare Corporation · May 2009
PRECISION OXYGEN CONCENTRATOR
K072348 · Precision Medical, Inc. · Oct 2008
HOMELOX
K081206 · Respironics, Inc. · Jul 2008
THE INVACARE FLYER, MODEL IPC 100
K071928 · Invacare Corp. · Dec 2007
L4 OXYGEN CONCENTRATOR
K061261 · Respironics, Inc. · Jun 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053230 · Merits Health Products Co., Ltd. · May 2006