Belun Ring BLR-200 (BLR-200)

FDA 510(k) K234110 · Belun Technology Company Limited

Substantially Equivalent

510(k) numberK234110

Submission

Device name
Belun Ring BLR-200 (BLR-200)
Applicant
Belun Technology Company Limited
Hong Kong, HK
Received
December 27, 2023
Decision date
October 11, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQA – Oximeter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

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K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional Philips Medizin Systeme Böblingen GmbH05/29/2026SE
K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional Shenzhen Imdk Medical Technology Co., Ltd.05/11/2026SE
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K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special Unimed Medical Supplies, Inc.04/14/2026SE
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K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional Shenzhen Best Electronics Co., Ltd.01/07/2026SE
K251751Spo2 Sensor CSS032DDQA · Traditional Shenzhen Ykd Technology Co., Ltd.12/19/2025SE
K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional Unimed Medical Supplies, Inc.12/01/2025SE
K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional Unimed Medical Supplies, Inc.12/01/2025SE

More from Unimed Medical Supplies, Inc.

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K222579Belun Sleep System BLS-100MNR · Traditional 02/23/2023SE
K211407Belun Ring BLR-100XDQA · Traditional 10/21/2021SE
K191417Belun RingDQA · Traditional 10/10/2019SE
K180174Belun RingDQA · Traditional 05/29/2018SE

Questions and answers

When was Belun Ring BLR-200 (BLR-200) cleared by the FDA?

Belun Ring BLR-200 (BLR-200) (K234110) received a 510(k) decision of Substantially Equivalent on October 11, 2024, 289 days after the submission was received.

What is the product code of K234110?

The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.