Cleared Traditional

Reusable SpO2 Sensors, Disposable SpO2 Sensors (K172981) - FDA 510(k) Clearance

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

K172981 · APK Technology Co., Ltd. · Anesthesiology device
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Jun 2018
Decision
254d
Days
Class 2
Risk

K172981 is an FDA 510(k) clearance for the Reusable SpO2 Sensors, Disposable SpO2 Sensors. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by APK Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 8, 2018 after a review of 254 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 APK Technology Co., Ltd. devices

Submission Details

510(k) Number K172981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date June 08, 2018
Days to Decision 254 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
114d slower than avg
Panel avg: 140d · This submission: 254d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 188
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K172981.
Optical Topography System ETG-4100
K172492 · Hitachi Healthcare Americas · Aug 2018
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K173123 · Shenzhen Imdk Medical Technology Co., Ltd. · Aug 2018
Pulse Oximeter
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Oximeter
K173045 · Shenzhen Greatmade Tech Limited · Jun 2018
Belun Ring
K180174 · Belun Technology Company Limited · May 2018
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
K172625 · Nonin Medical, Inc. · May 2018