Cleared Traditional

K173045 - Oximeter

K173045 is an FDA 510(k) clearance for Oximeter, manufactured by Shenzhen Greatmade Tech Limited. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K173045 · Shenzhen Greatmade Tech Limited · Anesthesiology device
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Jun 2018
Decision
250d
Days
Class 2
Risk

K173045 is an FDA 510(k) clearance for the Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Greatmade Tech Limited (Shenzhen, CN). The FDA issued a Cleared decision on June 5, 2018 after a review of 250 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 Shenzhen Greatmade Tech Limited devices

FDA 510(k) Submission Details - K173045

510(k) Number K173045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date June 05, 2018
Days to Decision 250 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
110d slower than avg
Panel avg: 140d · This submission: 250d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K173045.
Pulse Oximeter
K173123 · Shenzhen Imdk Medical Technology Co., Ltd. · Aug 2018
Pulse Oximeter
K172616 · Beijing Safe Heart Technology , Ltd. · Jul 2018
Reusable SpO2 Sensors, Disposable SpO2 Sensors
K172981 · APK Technology Co., Ltd. · Jun 2018
Belun Ring
K180174 · Belun Technology Company Limited · May 2018
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
K172625 · Nonin Medical, Inc. · May 2018
Pulse Oximeter
K172141 · Shanghai Berry Electronic Tech Co., Ltd. · Apr 2018