Cleared Traditional

Belun Ring (K180174) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K180174 · Belun Technology Company Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
127d
Days
Class 2
Risk

K180174 is an FDA 510(k) clearance for the Belun Ring. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Belun Technology Company Limited (Sha Tin, HK). The FDA issued a Cleared decision on May 29, 2018 after a review of 127 days - within the typical 510(k) review window.

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 Belun Technology Company Limited devices

Submission Details

510(k) Number K180174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2018
Decision Date May 29, 2018
Days to Decision 127 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
13d faster than avg
Panel avg: 140d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03439306 Completed Observational

Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study

Accuracy Validation of Belun SpO2 Pulse Oximeter FDA Submission Study

11
Patients (actual)
1
Site
Condition studied Hypoxia
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Arthur Ruiz Cabrera, M.D.
Sponsor Belun Technology Company Limited
Started 2017-03-15 → Primary completion 2017-03-17
Primary outcome
Collect SpO2 data for accuracy statistical analysis by 11 subjects
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K180174.
Pulse Oximeter
K172616 · Beijing Safe Heart Technology , Ltd. · Jul 2018
Reusable SpO2 Sensors, Disposable SpO2 Sensors
K172981 · APK Technology Co., Ltd. · Jun 2018
Oximeter
K173045 · Shenzhen Greatmade Tech Limited · Jun 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
Pulse Oximeter
K171241 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Mar 2018