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 Sep 10, 2012 as substantially equivalent to K102906 (Andon Health Co, Ltd., 2010) and 1 other predicate after a 126-day review. Its family tree reaches back 7 generations to 2000. 3 later devices descend from it.
- Decided
- Sep 10, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001670 (2000). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 6 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 5 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 4 generations backK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- 3 generations backK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
- 2 generations backK091500 Modification to:Fully Automatic Electronic Blood Pressure Monitor…Andon Health Co, Ltd. · 2009
- 1 generation backK110330 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2011
- This deviceK121372 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK160565 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK151460 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK140121 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K160565Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2016 · cites it directly0descendants
- K151460Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2015 · cites it directly0descendants
- K140121Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −6 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −5 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −4 | K080319 | KD-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| −3 | K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −2 | K091500 | Modification to:Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −1 | K110330 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2011 | — |
| 0 (this device) | K121372 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| +1 | K160565 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2016 | — |
| +1 | K151460 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2015 | — |
| +1 | K140121 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K102906 | Fully Automatic Electronic Blood Pressure MonitorSummary page 1…Andon Health Co., Ltd. Device: KD-5964 Fully Automatic Electronic Blood Pressure 1 Monitor 510(k) number: K102906 2 Manufacturer: Andon Health Co., Ltd. *KD-513LU and KD-513LC FullyAutomiatic Electronic Blood Pres… | 2010 |
| * | K110330 | Fully Automatic Electronic Blood Pressure MonitorSummary page 2…5 10(k) Files Device: KD-556J Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K110330 5.0 Device description KD-513LU and KD-513 LC Fully Automatic Electronic Blood Pressure Monitor are for use by medical pr… | 2011 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K160565 (Andon Health Co, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K102906.
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. 2012, 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-513LU and KD-513LC 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-4Scm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121372: 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/K121372
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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