Cleared Traditional

K211407 - Belun Ring BLR-100X

K211407 is an FDA 510(k) clearance for Belun Ring BLR-100X, manufactured by Belun Technology Company Limited. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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

FDA 510(k) Submission Details - K211407

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.

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 453
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