510(k) · Cleared
ClearedKD-322 Semi Automatic Electronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kodon (Tianjin)Electronic&Electrical Apparatus Co., · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 17, 2006 after a 143-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Feb 17, 2006
- Review
- 143 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 2 citing it directly.
- This deviceK052676 KD-322 Semi Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2006
- Descendant · cites it directly · 2 of its ownK080326 KD-391 Semi Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK083395 Semi-Fully Automatic Electronic Blood Pressure Monitor, Models…Andon Health Co, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK190207 Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK091739 Semi Automatic Electronic Blood Pressure Monitor, Models KD-3917, KD…Andon Health Co, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK091738 Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BDAndon Health Co, Ltd. · 2009
Most influential descendants
Showing 5 of 5 · See all- K080326KD-391 Semi Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008 · cites it directly2descendants
- K083395Semi-Fully Automatic Electronic Blood Pressure Monitor, Models…Andon Health Co, Ltd. · 2009 · cites it directly1descendant
- K190207Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd. · 2019 · 2 generations on0descendants
- K091739Semi Automatic Electronic Blood Pressure Monitor, Models KD-3917, KD 3909Andon Health Co, Ltd. · 2009 · 2 generations on0descendants
- K091738Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BDAndon Health Co, Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052676 | KD-322 Semi Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2006 | — |
| +1 | K080326 | KD-391 Semi Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| +1 | K083395 | Semi-Fully Automatic Electronic Blood Pressure Monitor, Models… | Andon Health Co, Ltd. | 2009 | — |
| +2 | K190207 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | 2019 | — |
| +2 | K091739 | Semi Automatic Electronic Blood Pressure Monitor, Models KD-3917, KD 3909 | Andon Health Co, Ltd. | 2009 | — |
| +2 | K091738 | Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BD | Andon Health Co, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2019 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K053035 | FDA’s K053035 is Acro Biotech LLC Rapid Benzoylecgonine Urine Test; Catalog# MET001000 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
What descends from it? (5)
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?
- Of its descendants, K080326 (Andon Health Co, Ltd., 2008) has gone furthest, with 2 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.
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?
The KD-322 Semi 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 8.6614 inches to 13.78 inches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052676: KD-322 Semi 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/K052676
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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