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 Feb 18, 2016 as substantially equivalent to K130325 (Shenzhen Pump Medical System Co., Ltd., 2013) after a 282-day review. Its family tree reaches back 3 generations to 2005. 2 later devices descend from it.
- Decided
- Feb 18, 2016
- Review
- 282 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052153 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 2 generations backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- 1 generation backK130325 Arm Automatic Blood Pressure MonitorShenzhen Pump Medical System Co., Ltd. · 2013
- This deviceK151258 Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK161712 Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK161708 Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −2 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| −1 | K130325 | Arm Automatic Blood Pressure Monitor | Shenzhen Pump Medical System Co., Ltd. | 2013 | — |
| 0 (this device) | K151258 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2016 | — |
| +1 | K161712 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2017 | — |
| +1 | K161708 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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 |
|---|---|---|---|
| * | K130325 | Arm Automatic Blood Pressure MonitorSummary page 4…l: Cardiovascular 3. Information for the 510(k) Cleared Device(Predicate device) Arm automatic blood pressure monitor, Model: BF1110, BF1112, BF1113 and BF1115, K130325, SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 4. Description of the Device Arm automatic blood pressure monitor is based on pressu… | 2013 |
What descends from it? (2)
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 11 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161712 (Shenzhen Pump Medical System Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130325.
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. 2016, 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 a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22c¢m to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.
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/K151258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151258: Arm automatic 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/K151258
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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