Cleared Traditional

K201360 - Reusable and Disposable SpO2 Sensors

K201360 is the FDA 510(k) clearance for Reusable and Disposable SpO2 Sensors by Xinkang Medical Instrument Co. , Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K201360 · Xinkang Medical Instrument Co. , Ltd. · Anesthesiology device
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Aug 2020
Decision
90d
Days
Class 2
Risk

K201360 is an FDA 510(k) clearance for the Reusable and Disposable SpO2 Sensors. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Xinkang Medical Instrument Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 19, 2020 after a review of 90 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 Xinkang Medical Instrument Co. , Ltd. devices

Submission Details

510(k) Number K201360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2020
Decision Date August 19, 2020
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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

Shenzhen Joyantech Consulting Co., Ltd.
James Tsai

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 367
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K201360.
Spo2 Sensor
K202851 · Jkh USA, LLC · Nov 2020
Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
K201770 · Masimo Corporation · Sep 2020
Pulse Oximeter
K200414 · Shenzhen Aeon Technology Co., Ltd. · Sep 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
K201179 · Covidien, LLC · Jul 2020
Oxxiom
K200537 · True Wearables, Inc. · Jul 2020
H500 Multi-Sensing Oximetry System
K192900 · Nonin Medical, Inc. · Jun 2020