Cleared Traditional

K152390 - Medke Oximetry Finger Sensor

K152390 is an FDA 510(k) clearance for Medke Oximetry Finger Sensor, manufactured by Shenzhen Medke Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K152390 · Shenzhen Medke Technology Co., Ltd. · Anesthesiology device
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Aug 2016
Decision
360d
Days
Class 2
Risk

K152390 is an FDA 510(k) clearance for the Medke Oximetry Finger Sensor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Medke Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 18, 2016 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medke Technology Co., Ltd. devices

FDA 510(k) Submission Details - K152390

510(k) Number K152390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2015
Decision Date August 18, 2016
Days to Decision 360 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 140d · This submission: 360d
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 Peers - DQA Oximeter

All 454
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K152390.
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
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Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso
K160865 · Nonin Medical, Inc. · Aug 2016
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