Cleared Traditional

K102245 - CARE ZY5BA OXYGEN CONCENTRATOR

K102245 is an FDA 510(k) clearance for CARE ZY5BA OXYGEN CONCENTRATOR, manufactured by Foshan Care Medical Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K102245 · Foshan Care Medical Technology Co., Ltd. · Anesthesiology device
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Nov 2010
Decision
92d
Days
Class 2
Risk

K102245 is an FDA 510(k) clearance for the CARE ZY5BA 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 Foshan Care Medical Technology Co., Ltd. (Nanshan, Shenzhen, CN). The FDA issued a Cleared decision on November 9, 2010 after a review of 92 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.

View all Foshan Care Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K102245

510(k) Number K102245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date November 09, 2010
Days to Decision 92 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
48d faster than avg
Panel avg: 140d · This submission: 92d
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 92
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