Cleared Special

K053229 - MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

K053229 is an FDA 510(k) clearance for MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS, manufactured by Merits Health Products Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Special 510(k) pathway after a 125-day FDA review.

K053229 · Merits Health Products Co., Ltd. · Anesthesiology device
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Mar 2006
Decision
125d
Days
Class 2
Risk

K053229 is an FDA 510(k) clearance for the MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS. 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 Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on March 23, 2006 after a review of 125 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merits Health Products Co., Ltd. devices

FDA 510(k) Submission Details - K053229

510(k) Number K053229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2005
Decision Date March 23, 2006
Days to Decision 125 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
15d faster than avg
Panel avg: 140d · This submission: 125d
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 211
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K053229.
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