510(k) · Cleared
ClearedElectronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Jumper Medical Equipment Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 27, 2023 as substantially equivalent to K182127 (Omron Healthcare, Inc., 2018) after a 175-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Oct 27, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042505 (2005). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 2 generations backK131742 HEM-6131Omron Healthcare, Inc. · 2013
- 1 generation backK182127 Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc. · 2018
- This deviceK231310 Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253126 Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253133 Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK241634 Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)Guangdong Xinyu Electronic and Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
- K253133Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K241634Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)Guangdong Xinyu Electronic and Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −2 | K131742 | HEM-6131 | Omron Healthcare, Inc. | 2013 | — |
| −1 | K182127 | Wrist Blood Pressure Monitor Model BP6100 | Omron Healthcare, Inc. | 2018 | — |
| 0 (this device) | K231310 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | 2023 | — |
| +1 | K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026 | — |
| +1 | K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026 | — |
| +1 | K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K182127 | Wrist Blood Pressure Monitor Model BP6100Summary page 4…DXN Regulation Number 870.1130 Regulatory Class II 5ˊPredicate Device [807.92(a)(3)] K182127, Omron Healthcare, Inc. Trade/Device Name Wrist Blood Pressure Monitor Model BP6100… | 2018 |
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 18 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253126 (Shenzhen Ziqing Medical Equipment Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K182127.
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. 2023, 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?
The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231310: 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/K231310
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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