510(k) · Cleared
ClearedPulse Oximeter (Model OHT60,OXH78)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cofoe Medical Technology Co., Ltd. · DQA Oximeter
Cleared on Jan 4, 2024 as substantially equivalent to K212665 (Huizhou Xiaoou Technology Co., Ltd., 2022) after a 337-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Jan 4, 2024
- Review
- 337 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 backK093757 MD300C1 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- 4 generations backK153021 Fingertip Pulse Oximeter A310Amemo, Inc. · 2016
- 3 generations backK173123 Pulse OximeterShenzhen Imdk Medical Technology Co., Ltd. · 2018
- 2 generations backK191430 Pulse OximeterShenzhen Yimi Life-Technology Co., Ltd. · 2019
- 1 generation backK212665 Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number-…Huizhou Xiaoou Technology Co., Ltd. · 2022
- This deviceK230277 Pulse Oximeter (Model OHT60,OXH78)Cofoe Medical Technology Co., Ltd. · 2024
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 | K093757 | MD300C1 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| −4 | K153021 | Fingertip Pulse Oximeter A310 | Amemo, Inc. | 2016 | — |
| −3 | K173123 | Pulse Oximeter | Shenzhen Imdk Medical Technology Co., Ltd. | 2018 | — |
| −2 | 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 | — |
| 0 (this device) | K230277 | Pulse Oximeter (Model OHT60,OXH78) | Cofoe Medical Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse…Summary page 6…Pulse Oximeter (SO811), Pulse Oximeter Page 1 of 7 510(k) Summary (SO911) 510(k) number: K212665 4.0 Indication for Use Statement The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the dev… | 2022 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.6 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. 2024, 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 intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230277: Pulse Oximeter (Model OHT60,OXH78).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230277
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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