510(k) · Cleared
ClearedPulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Yimi Life-Technology Co., Ltd. · DQA Oximeter
Cleared on Oct 18, 2019 as substantially equivalent to K173123 (Shenzhen Imdk Medical Technology Co., Ltd., 2018) after a 142-day review. Its family tree reaches back 6 generations to 2000. 7 later devices descend from it.
- Decided
- Oct 18, 2019
- Review
- 142 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001085 (2000). 7 later devices descend from it, 5 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 backK093757 MD300C1 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- 2 generations backK153021 Fingertip Pulse Oximeter A310Amemo, Inc. · 2016
- 1 generation backK173123 Pulse OximeterShenzhen Imdk Medical Technology Co., Ltd. · 2018
- This deviceK191430 Pulse OximeterShenzhen Yimi Life-Technology Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK212665 Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number-…Huizhou Xiaoou Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK202173 Pulse OximeterShenzhen AOJ Medical Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK232520 Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H…Shenzhen Smallsignal Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK240092 Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202…Shenzhen Yimi Life Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK230277 Pulse Oximeter (Model OHT60,OXH78)Cofoe Medical Technology Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212665Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse…Huizhou Xiaoou Technology Co., Ltd. · 2022 · cites it directly1descendant
- K202173Pulse OximeterShenzhen AOJ Medical Technology Co., Ltd. · 2020 · cites it directly1descendant
- K232520Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B…Shenzhen Smallsignal Technology Co., Ltd. · 2024 · 2 generations on0descendants
- K240092Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112…Shenzhen Yimi Life Technology Co., Ltd. · 2024 · cites it directly0descendants
- K230277Pulse Oximeter (Model OHT60,OXH78)Cofoe Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
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 | K093757 | MD300C1 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| −2 | K153021 | Fingertip Pulse Oximeter A310 | Amemo, Inc. | 2016 | — |
| −1 | K173123 | Pulse Oximeter | Shenzhen Imdk Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K191430 | Pulse Oximeter | Shenzhen Yimi Life-Technology Co., Ltd. | 2019 | — |
| +1 | K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711)… | Huizhou Xiaoou Technology Co., Ltd. | 2022 | — |
| +1 | K202173 | Pulse Oximeter | Shenzhen AOJ Medical Technology Co., Ltd. | 2020 | — |
| +2 | K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA… | Shenzhen Smallsignal Technology Co., Ltd. | 2024 | — |
| +1 | K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111… | Shenzhen Yimi Life Technology Co., Ltd. | 2024 | — |
| +2 | K230277 | Pulse Oximeter (Model OHT60,OXH78) | Cofoe Medical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K173123 | Pulse OximeterSummary page 4…ssociated with the current Submission submission. 4. Predicate Shenzhen IMDK Medical Technology Co., Ltd., C101H1 Pulse Oximeter / Device(s) K173123 5. Device The oximeter consists of probe, electronic circuits, and display and plastic Description enclosures… | 2018 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse… | 2022 | 1 |
| K202173 | Pulse Oximeter | 2020 | 1 |
| K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112… | 2024 | 0 |
| K202324 | Fingertip Pulse Oximeter | 2020 | 0 |
| K201384 | Pulse Oximeter | 2020 | 0 |
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 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K212665 (Huizhou Xiaoou Technology Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K173123.
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 reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191430: 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/K191430
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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