Cleared Traditional

Belun Ring BLR-100X (K211407) - FDA 510(k) Clearance

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

K211407 · Belun Technology Company Limited · Anesthesiology device
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Oct 2021
Decision
168d
Days
Class 2
Risk

K211407 is an FDA 510(k) clearance for the Belun Ring BLR-100X. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Belun Technology Company Limited (Sha Tin, CN). The FDA issued a Cleared decision on October 21, 2021 after a review of 168 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 Belun Technology Company Limited devices

Submission Details

510(k) Number K211407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2021
Decision Date October 21, 2021
Days to Decision 168 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
28d slower than avg
Panel avg: 140d · This submission: 168d
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 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K211407.
Pulse Oximeter
K211400 · Beijing Choice Electronic Technology Co., Ltd. · Feb 2022
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
K211632 · Shenzhen Narig Bio-Medical Technology Co., Ltd. · Jan 2022
Pulse Oximeter
K210305 · Dongguan Lingxin Technologies Co., Ltd. · Dec 2021
Carescape SpO2 - Masimo
K212876 · Masimo Corporation · Oct 2021
Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
K210032 · Leadtek Research, Inc. · Sep 2021
Fingertip Pulse Oximeter
K210274 · Zhuhai Linte Medical Instrument Co., Ltd. · Jul 2021