Cleared Traditional

K240840 - Oxygen Concentrator (ZY-10AB/115)

K240840 is an FDA 510(k) clearance for Oxygen Concentrator (ZY-10AB/115), 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 254-day FDA review.

K240840 · Foshan Care Medical Technology Co., Ltd. · Anesthesiology device
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Dec 2024
Decision
254d
Days
Class 2
Risk

K240840 is an FDA 510(k) clearance for the Oxygen Concentrator (ZY-10AB/115). 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. (Foshan, CN). The FDA issued a Cleared decision on December 6, 2024 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 Foshan Care Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K240840

510(k) Number K240840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2024
Decision Date December 06, 2024
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 91
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K240840.
Portable Oxygen Concentrator (Spirit-3)
K242736 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Jun 2025
Portable Oxygen Concentrator (P2-TOC)
K242718 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Feb 2025
Rugged Oxygen Generator (ROG) (RO01-00001)
K240561 · Molecular Products , Ltd. · Dec 2024
Oxygen Concentrator
K230969 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Nov 2023
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
K230702 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Oct 2023
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
K223740 · Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. · Oct 2023