Cleared Traditional

Finger Pulse Oximeter (K163135) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163135 · Shenzhen Fitfaith Technology Co.,Ltd · Anesthesiology device
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Sep 2017
Decision
315d
Days
Class 2
Risk

K163135 is an FDA 510(k) clearance for the Finger Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Fitfaith Technology Co.,Ltd (Guangming New District, Shenzhen, CN). The FDA issued a Cleared decision on September 19, 2017 after a review of 315 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 Fitfaith Technology Co.,Ltd devices

Submission Details

510(k) Number K163135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date September 19, 2017
Days to Decision 315 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
175d slower than avg
Panel avg: 140d · This submission: 315d
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 Peers - DQA Oximeter

All 200
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K163135.
Pulse Oximeter
K171241 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Mar 2018
Wrist Pulse Oximeter
K172366 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2018
The Nellcor pulse oximetry monitor interface cable
K172482 · Covidien · Dec 2017
Finger Type Pulse Oximeter
K151024 · Taidoc Technology Corporation · Mar 2016
Nellcor Bedside SpO2 Patient Monitoring System
K142865 · Covidien, LLC · Mar 2015
Nellcor Bedside Respiratory Patient Monitoring System
K141518 · Covidien · Mar 2015