Cleared Traditional

Oxygen Concentrator (K202389) - FDA 510(k) Clearance

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

K202389 · Foshan Mic Medical Technology Co., Ltd. · Anesthesiology device
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Apr 2022
Decision
595d
Days
Class 2
Risk

K202389 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 Foshan Mic Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on April 8, 2022 after a review of 595 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 Foshan Mic Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K202389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2020
Decision Date April 08, 2022
Days to Decision 595 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
455d slower than avg
Panel avg: 140d · This submission: 595d
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 K202389.
Inogen Rove 4 Portable Oxygen Concentrator
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K210371 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Jun 2022
Invacare Platinum 5NXG Oxygen Concentrator
K203210 · Invacare Corporation · Apr 2021
X-PLO2R
K203086 · Belluscura, LLC · Mar 2021
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K200890 · Invacare Corporation · Aug 2020