Cleared Traditional

K161560 - Fingertip Pulse Oximeter MD300CN310

K161560 is an FDA 510(k) clearance for Fingertip Pulse Oximeter MD300CN310, manufactured by Beijing Choice Electronic Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K161560 · Beijing Choice Electronic Technology Co., Ltd. · Anesthesiology device
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Oct 2016
Decision
121d
Days
Class 2
Risk

K161560 is an FDA 510(k) clearance for the Fingertip Pulse Oximeter MD300CN310. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 5, 2016 after a review of 121 days - within the typical 510(k) review window.

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 Beijing Choice Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K161560

510(k) Number K161560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2016
Decision Date October 05, 2016
Days to Decision 121 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
19d faster than avg
Panel avg: 140d · This submission: 121d
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 665
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K161560.
Masimo Disposable Transflectance Forehead Sensor
K160940 · Masimo Corporation · Nov 2016
Fingertip Pulse Oximeter A310
K153021 · Amemo, Inc. · Nov 2016
Fingertip Pulse Oximeter MD300CG11/MD300CG51
K160268 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2016
WiCap
K160582 · Athena Gtx · Sep 2016
Fingertip Pulse Oximeter
K152091 · Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. · Aug 2016
Medke Oximetry Finger Sensor
K152390 · Shenzhen Medke Technology Co., Ltd. · Aug 2016