510(k) · Cleared
ClearedPulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Aeon Technology Co., Ltd. · DQA Oximeter
Cleared on Sep 13, 2019 as substantially equivalent to K153021 (Amemo, Inc., 2016) after a 163-day review. Its family tree reaches back 5 generations to 2000. 4 later devices descend from it.
- Decided
- Sep 13, 2019
- Review
- 163 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001085 (2000). 4 later devices descend from it, 3 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 backK093757 MD300C1 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- 1 generation backK153021 Fingertip Pulse Oximeter A310Amemo, Inc. · 2016
- This deviceK190869 Pulse OximeterShenzhen Aeon Technology Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK200414 Pulse OximeterShenzhen Aeon Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK203812 Oxyfit Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210274 Fingertip Pulse OximeterZhuhai Linte Medical Instrument Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK201294 Pulse OximeterGuangdong Long Yao Electronic Technology Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K200414Pulse OximeterShenzhen Aeon Technology Co., Ltd. · 2020 · cites it directly1descendant
- K203812Oxyfit Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K210274Fingertip Pulse OximeterZhuhai Linte Medical Instrument Co., Ltd. · 2021 · cites it directly0descendants
- K201294Pulse OximeterGuangdong Long Yao Electronic Technology Co., Ltd. · 2020 · cites it directly0descendants
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 | K093757 | MD300C1 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| −1 | K153021 | Fingertip Pulse Oximeter A310 | Amemo, Inc. | 2016 | — |
| 0 (this device) | K190869 | Pulse Oximeter | Shenzhen Aeon Technology Co., Ltd. | 2019 | — |
| +1 | K200414 | Pulse Oximeter | Shenzhen Aeon Technology Co., Ltd. | 2020 | — |
| +2 | K203812 | Oxyfit Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2022 | — |
| +1 | K210274 | Fingertip Pulse Oximeter | Zhuhai Linte Medical Instrument Co., Ltd. | 2021 | — |
| +1 | K201294 | Pulse Oximeter | Guangdong Long Yao Electronic Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K153021 | Fingertip Pulse Oximeter A310Summary page 4…Technology Co., Ltd. is requesting clearance for Pulse Oximeter. It is comparable to the following legally marketed system: 1. AMEMO INC. Fingertip Pulse Oximeter under K153021. 5. Device Description The Pulse Oximeter is a battery powered device intended for use in measuring and display… | 2016 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K200414 (Shenzhen Aeon Technology Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K153021.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
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/K190869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190869: Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190869
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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