510(k) · Cleared
ClearedFinger Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Fitfaith Technology Co.,Ltd · DQA Oximeter
Cleared on Sep 19, 2017 as substantially equivalent to K140582 (Shenzhen Jumper Medical Equipment Co., Ltd., 2014) after a 315-day review. Its family tree reaches back 6 generations to 2000. 4 later devices descend from it.
- Decided
- Sep 19, 2017
- Review
- 315 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001085 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 5 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 4 generations backK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
- 3 generations backK073454 Fingertip Pulse Oximeter, Model CMS-50CContec Medical System Co., Ltd. · 2008
- 2 generations backK082641 Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd. · 2008
- 1 generation backK140582 Fingertip Pulse OximeterShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- This deviceK163135 Finger Pulse OximeterShenzhen Fitfaith Technology Co.,Ltd · 2017
- Descendant · cites it directly · 1 of its ownK203854 Pulse OximeterShenzhen Hexin Zondan Medical Equipment Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK213430 Fingertip Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213984 Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)Shenzhen Zhengkang Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK182401 B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff…Amzetta Technologies Private Limited · 2019
Most influential descendants
Showing 4 of 4 · See all- K203854Pulse OximeterShenzhen Hexin Zondan Medical Equipment Co., Ltd. · 2021 · cites it directly1descendant
- K213430Fingertip Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd. · 2022 · 2 generations on0descendants
- K213984Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)Shenzhen Zhengkang Technology Co., Ltd. · 2022 · cites it directly0descendants
- K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared…Amzetta Technologies Private Limited · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −5 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −4 | K070371 | Fingertip Pulse Oximeter MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | 2007 | — |
| −3 | K073454 | Fingertip Pulse Oximeter, Model CMS-50C | Contec Medical System Co., Ltd. | 2008 | — |
| −2 | K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DL | Contec Medical System Co., Ltd. | 2008 | — |
| −1 | K140582 | Fingertip Pulse Oximeter | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014 | — |
| 0 (this device) | K163135 | Finger Pulse Oximeter | Shenzhen Fitfaith Technology Co.,Ltd | 2017 | — |
| +1 | K203854 | Pulse Oximeter | Shenzhen Hexin Zondan Medical Equipment Co., Ltd. | 2021 | — |
| +2 | K213430 | Fingertip Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2022 | — |
| +1 | K213984 | Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) | Shenzhen Zhengkang Technology Co., Ltd. | 2022 | — |
| +1 | K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T… | Amzetta Technologies Private Limited | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K140582 | Fingertip Pulse OximeterSummary page 5…Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd. Device: JPD-500A Fingertip Pulse Oximeter 510(K) Number: K140582 4 Device Description The Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation… | 2014 |
What descends from it? (4)
3 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 17 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K203854 (Shenzhen Hexin Zondan Medical Equipment Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K140582.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163135 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163135: Finger Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163135
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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