Cleared Traditional

K200414 - Pulse Oximeter

K200414 is the FDA 510(k) clearance for Pulse Oximeter by Shenzhen Aeon Technology Co., Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K200414 · Shenzhen Aeon Technology Co., Ltd. · Anesthesiology device
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Sep 2020
Decision
217d
Days
Class 2
Risk

K200414 is an FDA 510(k) clearance for the Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Aeon Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 23, 2020 after a review of 217 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Shenzhen Aeon Technology Co., Ltd. devices

Submission Details

510(k) Number K200414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2020
Decision Date September 23, 2020
Days to Decision 217 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
77d slower than avg
Panel avg: 140d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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

Chonconn Medical Device Consulting Co., Ltd.
Kevin Wang

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 - DQA Oximeter

All 367
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K200414.
Pulse Oximeter
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Reusable and Disposable SpO2 Sensors
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GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
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Oxxiom
K200537 · True Wearables, Inc. · Jul 2020