Cleared Traditional

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) (K223740) - FDA 510(k) Clearance

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

K223740 · Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. · Anesthesiology device
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Oct 2023
Decision
295d
Days
Class 2
Risk

K223740 is an FDA 510(k) clearance for the Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5). 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 Konsung Bio-Medical Science and Technology Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on October 5, 2023 after a review of 295 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 Konsung Bio-Medical Science and Technology Co., Ltd. devices

Submission Details

510(k) Number K223740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2022
Decision Date October 05, 2023
Days to Decision 295 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 140d · This submission: 295d
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 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 66
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K223740.
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Inogen Rove 6
K230052 · Inogen, Inc. · Jun 2023
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K223379 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Jun 2023