510(k) · Cleared
ClearedFingertip Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Witleaf Medical Electronics Co., Ltd. · DQA Oximeter
Cleared on Dec 30, 2022 as substantially equivalent to K203854 (Shenzhen Hexin Zondan Medical Equipment Co., Ltd., 2021) after a 435-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Dec 30, 2022
- Review
- 435 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001085 (2000). No later device cites it as a predicate yet.
- Root · 8 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 7 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 6 generations backK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
- 5 generations backK073454 Fingertip Pulse Oximeter, Model CMS-50CContec Medical System Co., Ltd. · 2008
- 4 generations backK082641 Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd. · 2008
- 3 generations backK140582 Fingertip Pulse OximeterShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- 2 generations backK163135 Finger Pulse OximeterShenzhen Fitfaith Technology Co.,Ltd · 2017
- 1 generation backK203854 Pulse OximeterShenzhen Hexin Zondan Medical Equipment Co., Ltd. · 2021
- This deviceK213430 Fingertip Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −7 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −6 | K070371 | Fingertip Pulse Oximeter MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | 2007 | — |
| −5 | K073454 | Fingertip Pulse Oximeter, Model CMS-50C | Contec Medical System Co., Ltd. | 2008 | — |
| −4 | K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DL | Contec Medical System Co., Ltd. | 2008 | — |
| −3 | K140582 | Fingertip Pulse Oximeter | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014 | — |
| −2 | K163135 | Finger Pulse Oximeter | Shenzhen Fitfaith Technology Co.,Ltd | 2017 | — |
| −1 | K203854 | Pulse Oximeter | Shenzhen Hexin Zondan Medical Equipment Co., Ltd. | 2021 | — |
| 0 (this device) | K213430 | Fingertip Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K203854 | Pulse OximeterSummary page 4…Traditional 510(K) 4. Predicate Device Manufacturer: Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd Device name: Pulse Oximeter, A2, A3, A4, A5 510(K) Number: K203854 5. Device Description The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturatio… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
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?
This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
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/K213430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213430: 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/K213430
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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