510(k) · Cleared
ClearedArm Automatic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Pump Medical System Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 24, 2013 as substantially equivalent to K121932 (Omron Healthcare, Inc., 2012) after a 319-day review. Its family tree reaches back 2 generations to 2005. 4 later devices descend from it.
- Decided
- Dec 24, 2013
- Review
- 319 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052153 (2005). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 1 generation backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- This deviceK130325 Arm Automatic Blood Pressure MonitorShenzhen Pump Medical System Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK151258 Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK161712 Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK161708 Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK153033 Digital Blood Pressure MonitorSuzhou Sunspiri Co., Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K151258Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2016 · cites it directly2descendants
- K161712Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2017 · 2 generations on0descendants
- K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2016 · 2 generations on0descendants
- K153033Digital Blood Pressure MonitorSuzhou Sunspiri Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −1 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| 0 (this device) | K130325 | Arm Automatic Blood Pressure Monitor | Shenzhen Pump Medical System Co., Ltd. | 2013 | — |
| +1 | K151258 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2016 | — |
| +2 | K161712 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2017 | — |
| +2 | K161708 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2016 | — |
| +1 | K153033 | Digital Blood Pressure Monitor | Suzhou Sunspiri Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K121932 | Hem-7200-Z (BP742)Summary page 1…It is intended for measuring adult blood pressure and pulse rate over-the-counter. 3. Predicate Devices " Noninvasive blood pressure measurement system * K-number: K121932 * Product Code: DXN * Intended User Over the counter * Patient Population This device is intended for use on adults *Ind… | 2012 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151258 (Shenzhen Pump Medical System Co., Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K121932.
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. 2013, 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?
It is intended for measuring adult blood pressure and pulse rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130325 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130325: Arm Automatic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130325
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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