Cleared Traditional

Oxygen Concentrator (K230969) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230969 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Anesthesiology device
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Nov 2023
Decision
218d
Days
Class 2
Risk

K230969 is an FDA 510(k) clearance for the 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 Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on November 9, 2023 after a review of 218 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 Jiangsu Jumao X-Care Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K230969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2023
Decision Date November 09, 2023
Days to Decision 218 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 140d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 47
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K230969.
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 (ZY-10AB/115)
K240840 · Foshan Care Medical Technology Co., Ltd. · Dec 2024
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
Oxygen concentrator
K222920 · Zhengzhou Olive Electronic Technology Co., Ltd. · Jul 2023