510(k) · Cleared
ClearedFully Automatic Electronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 29, 2010 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Oct 29, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 5 citing it directly.
- This deviceK102906 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2010
- Descendant · cites it directly · 6 of its ownK162230 Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK183534 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2019
- Descendant · 3 generations on · 4 of its ownK210770 Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK121372 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK121470 Fully Automatic Wireless Blood Pressure Wrist MonitorAndon Health Co, Ltd. · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. · 2016 · cites it directly6descendants
- K183534Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2019 · 2 generations on5descendants
- K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021 · 3 generations on4descendants
- K121372Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2012 · cites it directly3descendants
- K121470Fully Automatic Wireless Blood Pressure Wrist MonitorAndon Health Co, Ltd. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102906 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2010 | — |
| +1 | K162230 | Fully Automatic Electronic Blood Pressure Monitor | Adon Health Co., Ltd. | 2016 | — |
| +2 | K183534 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2019 | — |
| +3 | K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2021 | — |
| +1 | K121372 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| +1 | K121470 | Fully Automatic Wireless Blood Pressure Wrist Monitor | Andon Health Co, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162230 | Fully Automatic Electronic Blood Pressure Monitor | 2016 | 6 |
| K121372 | Fully Automatic Electronic Blood Pressure Monitor | 2012 | 3 |
| K121470 | Fully Automatic Wireless Blood Pressure Wrist Monitor | 2012 | 3 |
| K162915 | Fully Automatic Electronic Blood Pressure Monitor | 2017 | 2 |
| K111830 | Fully Automatic Electronic Blood Pressure Monitor Model KD-7902BTJ, Fully Automatic… | 2011 | 1 |
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?
- Of its descendants, K162230 (Adon Health Co., Ltd., 2016) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
https://510kreport.com/device/K102906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102906: Fully Automatic Electronic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102906
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026