510(k) · Cleared
ClearedKD-936 Fully Automatic Wireless 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 Jun 1, 2012 as substantially equivalent to K102939 (Andon Health Co, Ltd., 2011) after an 88-day review. Its family tree reaches back 7 generations to 2000. 27 later devices descend from it.
- Decided
- Jun 1, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001670 (2000). 27 later devices descend from it, 6 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 backK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
- 1 generation backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- This deviceK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- Descendant · cites it directly · 13 of its ownK141984 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2015
- Descendant · cites it directly · 8 of its ownK140067 QardioarmQardio, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK162668 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2017
- Descendant · 3 generations on · 4 of its ownK210770 Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K141984Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2015 · cites it directly13descendants
- K140067QardioarmQardio, Inc. · 2014 · cites it directly8descendants
- K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015 · 2 generations on6descendants
- K162668Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2017 · 2 generations on5descendants
- K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021 · 3 generations on4descendants
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 | K101950 | Fully Automatic Electronic Blood Pressure Monitor Model KD-930 | Andon Health Co, Ltd. | 2010 | — |
| −1 | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931 | Andon Health Co, Ltd. | 2011 | — |
| 0 (this device) | K120672 | KD-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| +1 | K141984 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2015 | — |
| +1 | K140067 | Qardioarm | Qardio, Inc. | 2014 | — |
| +2 | K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | Fudakang Industrial Co., Ltd. | 2015 | — |
| +2 | K162668 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2017 | — |
| +3 | K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931Summary page 1…Andlon Health Co., Ltd. Device: iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock 510(k) number: K102939 5- 1 KD- 936 Fully Automatic Wireles s Blood Pressure Dock F… | 2011 |
What descends from it? (27)
See all 276 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141984 | Fully Automatic Electronic Blood Pressure Monitor | 2015 | 13 |
| K140067 | Qardioarm | 2014 | 8 |
| K133125 | Withings Blood Presure Monitor | 2014 | 2 |
| K162144 | iHealth Wireless Blood Pressure Monitor | 2017 | 1 |
| K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared… | 2019 | 0 |
| K171062 | BP5S Wireless Blood Pressure Monitor | 2017 | 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 1.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K141984 (Andon Health Co, Ltd., 2015) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K102939.
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-936 Fully Automatic Wireless 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 as stated in the FDA summary.
https://510kreport.com/device/K120672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120672: KD-936 Fully Automatic Wireless 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/K120672
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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