Cleared Traditional

K173368 - Reusable & Disposable SpO2 Sensors

K173368 is the FDA 510(k) clearance for Reusable & Disposable SpO2 Sensors by Shenzhen Coreray Technology, Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K173368 · Shenzhen Coreray Technology, Ltd. · Anesthesiology device
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Aug 2018
Decision
309d
Days
Class 2
Risk

K173368 is an FDA 510(k) clearance for the Reusable & Disposable SpO2 Sensors. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Coreray Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 31, 2018 after a review of 309 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 Coreray Technology, Ltd. devices

Submission Details

510(k) Number K173368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2017
Decision Date August 31, 2018
Days to Decision 309 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
169d slower than avg
Panel avg: 140d · This submission: 309d
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.
Field Fu

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 K173368.
Fingertip Pulse Oximeter
K181503 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2018
BB-613 Watch Oximeter
K181006 · Bio-Beat Technologies , Ltd. · Sep 2018
Disposable SpO2 Sensors, Reusable SpO2 Sensors
K181270 · Orantech, Inc. · Sep 2018
Optical Topography System ETG-4100
K172492 · Hitachi Healthcare Americas · Aug 2018
Pulse Oximeter
K173123 · Shenzhen Imdk Medical Technology Co., Ltd. · Aug 2018
Pulse Oximeter
K172616 · Beijing Safe Heart Technology , Ltd. · Jul 2018