Cleared Traditional

K252965 - Oxygen Concentrator (OX-5A, OX-5C)

K252965 is an FDA 510(k) clearance for Oxygen Concentrator (OX-5A, manufactured by Oxytek 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 254-day FDA review.

K252965 · Oxytek Medical Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
254d
Days
Class 2
Risk

K252965 is an FDA 510(k) clearance for the Oxygen Concentrator (OX-5A, OX-5C). 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 Oxytek Medical Technology Co., Ltd. (Chencun Town, Shunde District, Foshan, CN). The FDA issued a Cleared decision on May 29, 2026 after a review of 254 days - an extended review 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: 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 Oxytek Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K252965

510(k) Number K252965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2025
Decision Date May 29, 2026
Days to Decision 254 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
114d slower than avg
Panel avg: 140d · This submission: 254d
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 Consultant

Share Info (Guangzhou) Medical Consultant , Ltd.
Cassie Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 169
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K252965.
Portable Oxygen Concentrator (PO1 5B, PO1 6B)
K260171 · BMC Medical Co., Ltd. · Aug 2026
Portable Oxygen Concentrator
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OxyGo Portable Oxygen Concentrator (1400-7000)
K252407 · Mv Life, LLC · Apr 2026
DeVilbiss 5 Liter Oxygen Concentrator (555)
K253549 · Devilbiss Healthcare, LLC · Mar 2026
Oxygen Concentrator (J10A)
K251534 · Foshan Kycare Medical Equipment Co., Ltd. · Dec 2025
Oxygen Concentrator-P2-O5E
K251764 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Dec 2025