510(k) · Cleared
ClearedElectronic Blood Pressure Monitor for Upper Arm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jinxinbao Electronic Co.,Ltd · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 17, 2013 as substantially equivalent to K120554 (Sejoy Electronics & Instruments Co., Ltd., 2012) after a 231-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Sep 17, 2013
- Review
- 231 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K982481 (1998). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 5 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 4 generations backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- 3 generations backK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- 2 generations backK111686 A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011
- 1 generation backK120554 Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type…Sejoy Electronics & Instruments Co., Ltd. · 2012
- This deviceK130232 Electronic Blood Pressure Monitor for Upper ArmJinxinbao Electronic Co.,Ltd · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −5 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −4 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| −3 | K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2008 | — |
| −2 | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure Monitors | A&D Company, Ltd. | 2011 | — |
| −1 | K120554 | Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully… | Sejoy Electronics & Instruments Co., Ltd. | 2012 | — |
| 0 (this device) | K130232 | Electronic Blood Pressure Monitor for Upper Arm | Jinxinbao Electronic Co.,Ltd | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K120554 | Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully Automatic…Summary page 1…lation Number: 21 CFR 870.1130 Product Code: DXN *Predicate Device: Fully Automatic Digital Blood Pressure Monitor, Model BP-1 307. K 1205 54 -Device Description: BPA-002 Electronic Blood Pressure Monitor for Upper Arm uses an inflatable cuff which is wrapped around… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K120554.
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?
BPA-002 Electronic Blood Pressure Monitor for Upper Arm is Intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel.
It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130232: Electronic Blood Pressure Monitor for Upper Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130232
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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