Cleared Traditional

K123801 - FINGER PULSE OXIMETER

K123801 is the FDA 510(k) clearance for FINGER PULSE OXIMETER by Shenzhen Kingyield Technology Co., Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K123801 · Shenzhen Kingyield Technology Co., Ltd. · Anesthesiology device
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May 2013
Decision
169d
Days
Class 2
Risk

K123801 is an FDA 510(k) clearance for the FINGER PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Kingyield Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 28, 2013 after a review of 169 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 Kingyield Technology Co., Ltd. devices

Submission Details

510(k) Number K123801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date May 28, 2013
Days to Decision 169 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
29d slower than avg
Panel avg: 140d · This submission: 169d
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 368
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K123801.
PULSE OXIMETER
K131021 · Nonin Medical, Inc. · Sep 2013
IHEALTH FINGERTIP PULSE OXIMETER
K131111 · Andon Health Co, Ltd. · Sep 2013
VITAL SIGNS MONITOR
K131818 · Edan Instruments, Inc. · Aug 2013
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
K120984 · Masimo Corporation · Apr 2013
FINGERTIP PULSE OXIMETER
K121697 · Andon Health Co, Ltd. · Oct 2012
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
K121806 · Covidien · Sep 2012