510(k) · Cleared
ClearedWrist Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technololgy Co., Ltd. · DQA Oximeter
Cleared on Feb 4, 2013 as substantially equivalent to K081125 (Beijing Choice Electronic Technololgy Co., Ltd., 2008) after a 207-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it.
- Decided
- Feb 4, 2013
- Review
- 207 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001085 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 4 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 3 generations backK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
- 2 generations backK072825 Fingertip Pulse Oximeter, Model MD300IBeijing Choice Electronic Technololgy Co., Ltd. · 2008
- 1 generation backK081125 Wrist Pulse Oximeter MD300WBeijing Choice Electronic Technololgy Co., Ltd. · 2008
- This deviceK122046 Wrist Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK132407 Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK152089 Wrist Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK151835 Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014 · cites it directly1descendant
- K152089Wrist Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd. · 2016 · cites it directly0descendants
- K151835Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −4 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −3 | K070371 | Fingertip Pulse Oximeter MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | 2007 | — |
| −2 | K072825 | Fingertip Pulse Oximeter, Model MD300I | Beijing Choice Electronic Technololgy Co., Ltd. | 2008 | — |
| −1 | K081125 | Wrist Pulse Oximeter MD300W | Beijing Choice Electronic Technololgy Co., Ltd. | 2008 | — |
| 0 (this device) | K122046 | Wrist Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2013 | — |
| +1 | K132407 | Vital Signs Patch System (in Short VSP) | Lifewatch Technologies, Ltd. | 2014 | — |
| +1 | K152089 | Wrist Pulse Oximeter | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016 | — |
| +2 | K151835 | Vital Signs Patch System | Lifewatch Technologies, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K081125 | Wrist Pulse Oximeter MD300WSummary page 1…ts of 2l CFR 807.92. The assigned 5 10(k) number is: K122046 Statement Wrist Pulse Oximeters MD300W4 is a modification device to Wrist Pulse Oximeter MD300W (K081 125). Their differences between them are listed below: MD300W4 MD300W Di… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132407 (Lifewatch Technologies, Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K081125.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in intemnist/ surgery, Anesthesia, intensive care and etc).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122046: Wrist 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/K122046
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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