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 Apr 29, 2015 as substantially equivalent to K120672 (Andon Health Co, Ltd., 2012) after a 282-day review. Its family tree reaches back 8 generations to 2000. 13 later devices descend from it.
- Decided
- Apr 29, 2015
- Review
- 282 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001670 (2000). 13 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 7 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 6 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 5 generations backK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- 4 generations backK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
- 3 generations backK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
- 2 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 1 generation backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- This deviceK141984 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK162668 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2017
- Descendant · 2 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 ownK192609 Globalcare Blood Pressure MonitorGlobalcare Medical Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK234041 Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully…Andon Health Co, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK222160 GUS610 Blood pressure monitorGlobalcare Medical Technology Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K162668Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2017 · cites it directly5descendants
- K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021 · 2 generations on4descendants
- K192609Globalcare Blood Pressure MonitorGlobalcare Medical Technology Co., Ltd. · 2020 · cites it directly3descendants
- K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…Andon Health Co, Ltd. · 2024 · 3 generations on1descendant
- K222160GUS610 Blood pressure monitorGlobalcare Medical Technology Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −7 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −6 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −5 | K080319 | KD-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| −4 | K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −3 | K101950 | Fully Automatic Electronic Blood Pressure Monitor Model KD-930 | Andon Health Co, Ltd. | 2010 | — |
| −2 | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931 | Andon Health Co, Ltd. | 2011 | — |
| −1 | K120672 | KD-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| 0 (this device) | K141984 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2015 | — |
| +1 | K162668 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2017 | — |
| +2 | K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2021 | — |
| +1 | K192609 | Globalcare Blood Pressure Monitor | Globalcare Medical Technology Co., Ltd. | 2020 | — |
| +3 | K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic… | Andon Health Co, Ltd. | 2024 | — |
| +2 | K222160 | GUS610 Blood pressure monitor | Globalcare Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K120672 | KD-936 Fully Automatic Wireless Blood Pressure MonitorSummary page 4…Cardiovascular 4.0 Predicate device information Manufacturer: Andon Health Co., Ltd. Device: KD-936 Fully Automatic Wireless Blood Pressure Monitor 510(k) number: K120672 1 of 3 KD-927,KD-928 Fully Automatic Electronic Blood Pressu… | 2012 |
What descends from it? (13)
See all 134 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 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K162668 (Andon Health Co, Ltd., 2017) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K120672.
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. 2015, 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-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are
for use by medical professionals or at home and are 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 as stated in the FDA summary.
https://510kreport.com/device/K141984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141984: Fully Automatic Electronic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141984
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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