Cleared Traditional

Portable Oxygen Concentrator, model: P2-E6 (K210371) - FDA 510(k) Clearance

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

K210371 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Anesthesiology device
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Jun 2022
Decision
480d
Days
Class 2
Risk

K210371 is an FDA 510(k) clearance for the Portable Oxygen Concentrator, model: P2-E6. 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 3, 2022 after a review of 480 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Qingdao Kingon Medical Science and Technology Co., Ltd. devices

Submission Details

510(k) Number K210371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date June 03, 2022
Days to Decision 480 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
340d slower than avg
Panel avg: 140d · This submission: 480d
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

Qimmiq Medical Consulting Service Co., Ltd.
You Yijie

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 47
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