510(k) · Cleared
ClearedBelun Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belun Technology Company Limited · DQA Oximeter
Cleared on May 29, 2018 as substantially equivalent to K070371 (Beijing Choice Electronic Technololgy Co., Ltd., 2007) after a 127-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- May 29, 2018
- Review
- 127 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001085 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 2 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 1 generation backK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
- This deviceK180174 Belun RingBelun Technology Company Limited · 2018
- Descendant · cites it directly · 3 of its ownK191417 Belun RingBelun Technology Company Limited · 2019
- Descendant · 2 generations on · 2 of its ownK211407 Belun Ring BLR-100XBelun Technology Company Limited · 2021
- Descendant · 3 generations on · 1 of its ownK221361 circul™ pro RingBodimetrics, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK234110 Belun Ring BLR-200 (BLR-200)Belun Technology Company Limited · 2024
Most influential descendants
Showing 4 of 4 · See all- K191417Belun RingBelun Technology Company Limited · 2019 · cites it directly3descendants
- K211407Belun Ring BLR-100XBelun Technology Company Limited · 2021 · 2 generations on2descendants
- K221361circul™ pro RingBodimetrics, LLC · 2023 · 3 generations on1descendant
- K234110Belun Ring BLR-200 (BLR-200)Belun Technology Company Limited · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −2 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −1 | K070371 | Fingertip Pulse Oximeter MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | 2007 | — |
| 0 (this device) | K180174 | Belun Ring | Belun Technology Company Limited | 2018 | — |
| +1 | K191417 | Belun Ring | Belun Technology Company Limited | 2019 | — |
| +2 | K211407 | Belun Ring BLR-100X | Belun Technology Company Limited | 2021 | — |
| +3 | K221361 | circul™ pro Ring | Bodimetrics, LLC | 2023 | — |
| +3 | K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070371 | Fingertip Pulse Oximeter MD300CSummary page 4…700) Regulatory Class: II Product Code: DQA III. PREDICATE DEVICE The identified predicates: SONOSAT-W01T Wrist Pulse Oximeter (K070371, Jiangsu Konsung Bio-Medical Science and Technology Co.,Ltd.) The reference device: PulseOx SPO7500 Pu… | 2007 |
| † | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191417 | Belun Ring | 2019 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191417 (Belun Technology Company Limited, 2019) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K070371.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
Belun Ring BLR-100 is a non-invasive and stand-alone pulse oximeter, intending for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment. It is not intended for single-use and out-of-hospital transport use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180174: Belun Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180174
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026