510(k) · Cleared
ClearedFingertip Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · DQA Oximeter
Cleared on Oct 15, 2012 as substantially equivalent to K093757 (Beijing Choice Electronic Technololgy Co., Ltd., 2010) after a 130-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Oct 15, 2012
- Review
- 130 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001085 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 3 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 2 generations backK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
- 1 generation backK093757 MD300C1 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- This deviceK121697 Fingertip Pulse OximeterAndon Health Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK131111 Ihealth Fingertip Pulse OximeterAndon Health Co, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131111Ihealth Fingertip Pulse OximeterAndon Health Co, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −3 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −2 | K070371 | Fingertip Pulse Oximeter MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | 2007 | — |
| −1 | K093757 | MD300C1 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| 0 (this device) | K121697 | Fingertip Pulse Oximeter | Andon Health Co, Ltd. | 2012 | — |
| +1 | K131111 | Ihealth Fingertip Pulse Oximeter | Andon Health Co, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K093757 | MD300C1 Fingertip Pulse OximeterSummary page 1…evice information Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Device: MOSOOCi Fingertip Pulse Oximeter 510(k) number: K093757 5- 1 APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131111 | Ihealth Fingertip Pulse Oximeter | 2013 | 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 12 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131111 (Andon Health Co, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K093757.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121697: Fingertip 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/K121697
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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