510(k) · Cleared
ClearedFully Automatic Electronc Blood Pressure Monitor, Model, KD-5962
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 4, 2009 as substantially equivalent to K083317 (Andon Health Co, Ltd., 2009) after a 73-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- Jun 4, 2009
- Review
- 73 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001670 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 3 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 2 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 1 generation backK083317 Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902Andon Health Co, Ltd. · 2009
- This deviceK090771 Fully Automatic Electronc Blood Pressure Monitor, Model, KD-5962Andon Health Co, Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK093528 Fully Automatic Electronic Blood Pressure Monitor Model KD-5963…Andon Health Co, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK102609 KD-5966 Series Fully Automatic Electronic Blood Pressure MonitorAndon Medical Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK100940 Fully Automatic Electronic Blood Pressure Monitor, Model KD-5965Andon Health Co, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK093387 Fully Automatic Electronic Blood Pressure Monitor Model KD-5961…Andon Health Co, Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K093528Fully Automatic Electronic Blood Pressure Monitor Model KD-5963, KD-7963Andon Health Co, Ltd. · 2009 · cites it directly2descendants
- K102609KD-5966 Series Fully Automatic Electronic Blood Pressure MonitorAndon Medical Co., Ltd. · 2010 · 2 generations on0descendants
- K100940Fully Automatic Electronic Blood Pressure Monitor, Model KD-5965Andon Health Co, Ltd. · 2010 · 2 generations on0descendants
- K093387Fully Automatic Electronic Blood Pressure Monitor Model KD-5961, KD-5962, KD-5902Andon Health Co, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −3 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −2 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −1 | K083317 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902 | Andon Health Co, Ltd. | 2009 | — |
| 0 (this device) | K090771 | Fully Automatic Electronc Blood Pressure Monitor, Model, KD-5962 | Andon Health Co, Ltd. | 2009 | — |
| +1 | K093528 | Fully Automatic Electronic Blood Pressure Monitor Model KD-5963, KD-7963 | Andon Health Co, Ltd. | 2009 | — |
| +2 | K102609 | KD-5966 Series Fully Automatic Electronic Blood Pressure Monitor | Andon Medical Co., Ltd. | 2010 | — |
| +2 | K100940 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-5965 | Andon Health Co, Ltd. | 2010 | — |
| +1 | K093387 | Fully Automatic Electronic Blood Pressure Monitor Model KD-5961, KD-5962… | Andon Health Co, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K083317 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902Summary page 3…62 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5902 whose 51 0(k) number is K083317. The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable… | 2009 |
What descends from it? (4)
2 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 9 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K093528 (Andon Health Co, Ltd., 2009) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K083317.
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. 2009, 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-5962 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/K090771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090771: Fully Automatic Electronc Blood Pressure Monitor, Model, KD-5962.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090771
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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