Cleared Traditional

Pulse Oximeter (K190869) - FDA 510(k) Clearance

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

K190869 · Shenzhen Aeon Technology Co., Ltd. · Anesthesiology device
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Sep 2019
Decision
163d
Days
Class 2
Risk

K190869 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 13, 2019 after a review of 163 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 K190869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2019
Decision Date September 13, 2019
Days to Decision 163 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
24d slower than avg
Panel avg: 139d · This submission: 163d
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 725
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K190869.
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