510(k) · Cleared
ClearedYUWELL Finger Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · DQA Oximeter
Cleared on Aug 16, 2022 as substantially equivalent to K101577 (Beijing Choice Electronic Technololgy Co., Ltd., 2010) after a 379-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Aug 16, 2022
- Review
- 379 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001085 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 3 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 2 generations backK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
- 1 generation backK101577 Modification to:Fingertip Pulse Oximeter, Model MD300C SeriesBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- This deviceK212385 YUWELL Finger Pulse OximeterJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK252805 YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −3 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −2 | K070371 | Fingertip Pulse Oximeter MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | 2007 | — |
| −1 | K101577 | Modification to:Fingertip Pulse Oximeter, Model MD300C Series | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| 0 (this device) | K212385 | YUWELL Finger Pulse Oximeter | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022 | — |
| +1 | K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K101577 | Modification to:Fingertip Pulse Oximeter, Model MD300C SeriesSummary page 4…DQA Regulation Number: 21 CFR 870.2700 Classification Name: Oximeter Device Classification: Class Ⅱ FDA 510 (k) #: K101577 4、DESCRIPTION OF THE DEVICE The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device whi… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | 2026 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252805 (Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The YUWELL@ Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212385: YUWELL Finger Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212385
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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