Cleared Traditional

Portable Oxygen Concentrator (Model: P2-E7, P2-E) (K223379) - FDA 510(k) Clearance

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

K223379 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Anesthesiology device
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Jun 2023
Decision
227d
Days
Class 2
Risk

K223379 is an FDA 510(k) clearance for the Portable Oxygen Concentrator (Model: P2-E7, P2-E). 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 Qingdao Kingon Medical Science and Technology Co., Ltd. (Qingdao Free Trade Zone, CN). The FDA issued a Cleared decision on June 22, 2023 after a review of 227 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 Qingdao Kingon Medical Science and Technology Co., Ltd. devices

Submission Details

510(k) Number K223379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2022
Decision Date June 22, 2023
Days to Decision 227 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
87d slower than avg
Panel avg: 140d · This submission: 227d
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 K223379.
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
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Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
K213825 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Apr 2023
Inogen Rove 4 Portable Oxygen Concentrator
K222086 · Inogen · Dec 2022