Cleared Special

K061261 - L4 OXYGEN CONCENTRATOR

K061261 is an FDA 510(k) clearance for L4 OXYGEN CONCENTRATOR, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Special 510(k) pathway after a 54-day FDA review.

K061261 · Respironics, Inc. · Anesthesiology device
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Jun 2006
Decision
54d
Days
Class 2
Risk

K061261 is an FDA 510(k) clearance for the L4 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 Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on June 28, 2006 after a review of 54 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K061261

510(k) Number K061261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2006
Decision Date June 28, 2006
Days to Decision 54 days
Submission Type Special
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
86d faster than avg
Panel avg: 140d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 209
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