510(k) · Cleared
ClearedFingertip 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 Oct 16, 2013 as substantially equivalent to K070371 (Beijing Choice Electronic Technololgy Co., Ltd., 2007) after a 184-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 16, 2013
- Review
- 184 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001085 (2000). 2 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 deviceK131047 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK160268 Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK221798 Finger Pulse Oximeter, Model: X1906PShenzhen Changkun Technology Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView 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) | K131047 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2013 | — |
| +1 | K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51 | Beijing Choice Electronic Technology Co., Ltd. | 2016 | — |
| +2 | K221798 | Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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 2…market Notification 510(k) Submission -- Sec 3 510(k) Summary pulse rate of adult. adolescent, child and infant patient in hospital. 3.4 Predicate Device 510(k) Number: K070371 Common Name: Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300C Classification Name: Oximeter Devi… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51 | 2016 | 1 |
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 5.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K160268 (Beijing Choice Electronic Technology Co., Ltd., 2016) has gone furthest, with 1 descendant 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. 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 Fingertip Pulse Oximeter MD300CB3 is a portable, non-invasive device intended for
spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult,
adolescent, child and infant patient in hospital.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131047: Fingertip 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/K131047
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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