Cleared Traditional

K163135 - Finger Pulse Oximeter

K163135 is an FDA 510(k) clearance for Finger Pulse Oximeter, manufactured by Shenzhen Fitfaith Technology Co.,Ltd. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 315-day FDA review.

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

FDA 510(k) Submission Details - K163135

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.

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 478
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
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K172366 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2018
The Nellcor pulse oximetry monitor interface cable
K172482 · Covidien · Dec 2017
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
K162675 · Masimo Corporation · Dec 2016
Model X-100C CO-Met™ Oximetry System
K160231 · Nonin Medical, Inc. · Dec 2016
Masimo Disposable Transflectance Forehead Sensor
K160940 · Masimo Corporation · Nov 2016