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 May 16, 2019 as substantially equivalent to K162230 (Adon Health Co., Ltd., 2016) after a 148-day review. Its family tree reaches back 2 generations to 2010. 5 later devices descend from it.
- Decided
- May 16, 2019
- Review
- 148 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K102906 (2010). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK102906 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2010
- 1 generation backK162230 Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. · 2016
- This deviceK183534 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2019
- Descendant · cites it directly · 4 of its ownK210770 Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK234041 Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully…Andon Health Co, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK251113 iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth…Andon Health Co, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK222887 Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure…Famidoc Technology Company Limited · 2023
- Descendant · 2 generations on · 0 of its ownK222869 Arm Blood Pressure MonitorAndon Health Co, Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021 · cites it directly4descendants
- K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…Andon Health Co, Ltd. · 2024 · 2 generations on1descendant
- K251113iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro Wireless…Andon Health Co, Ltd. · 2025 · 3 generations on0descendants
- K222887Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure MonitorFamidoc Technology Company Limited · 2023 · 2 generations on0descendants
- K222869Arm Blood Pressure MonitorAndon Health Co, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K183534 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2019 | — |
| +1 | K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2021 | — |
| +2 | K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic… | Andon Health Co, Ltd. | 2024 | — |
| +3 | K251113 | iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro… | Andon Health Co, Ltd. | 2025 | — |
| +2 | K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | Famidoc Technology Company Limited | 2023 | — |
| +2 | K222869 | Arm Blood Pressure Monitor | Andon Health Co, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K162230 | Fully Automatic Electronic Blood Pressure MonitorSummary page 4…Cardiovascular 4.0 Predicate device information Manufacturer: Andon Health Co., Ltd. Device: KD-5920 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K162230 5- 1… | 2016 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | 2021 | 4 |
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 9 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210770 (Andon Health Co, Ltd., 2021) has gone furthest, with 4 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. 2019, 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 | — |
What is it indicated for?
KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
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/K183534 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183534: Fully Automatic Electronic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183534
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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