Cleared Traditional

K161938 - Fingertip Pulse Oximeter

K161938 is an FDA 510(k) clearance for Fingertip Pulse Oximeter, manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K161938 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Anesthesiology device
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May 2017
Decision
298d
Days
Class 2
Risk

K161938 is an FDA 510(k) clearance for the Fingertip Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Xuzhou Yongkang Electronic Science Technology Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on May 8, 2017 after a review of 298 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 Xuzhou Yongkang Electronic Science Technology Co., Ltd. devices

FDA 510(k) Submission Details - K161938

510(k) Number K161938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2016
Decision Date May 08, 2017
Days to Decision 298 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
158d slower than avg
Panel avg: 140d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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

Beijing Believe Technology Service Co., Ltd.
RAY 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 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K161938.
Finger Pulse Oximeter
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Guardian Angel GA1000 Digital Vital Sign Monitoring System
K162580 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2017
Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
K162014 · Bluepoint Medical GmbH & Co. KG · Feb 2017
Caremed Reusable & Disposable SPO2 Sensors
K153184 · Shenzhen Caremed Medical Technology Co., Ltd. · Jan 2017