510(k) · Cleared
ClearedArm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully Automatic Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sejoy Electronics & Instruments Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 10, 2012 as substantially equivalent to K111686 (A&D Company, Ltd., 2011) after a 169-day review. Its family tree reaches back 5 generations to 1998. 3 later devices descend from it.
- Decided
- Aug 10, 2012
- Review
- 169 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K982481 (1998). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 4 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 3 generations backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- 2 generations backK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- 1 generation backK111686 A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011
- This deviceK120554 Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type…Sejoy Electronics & Instruments Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK161577 Arm-Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK150545 Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305…Sejoy Electronics & Instruments Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK130232 Electronic Blood Pressure Monitor for Upper ArmJinxinbao Electronic Co.,Ltd · 2013
Most influential descendants
Showing 3 of 3 · See all- K161577Arm-Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd. · 2017 · cites it directly0descendants
- K150545Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326…Sejoy Electronics & Instruments Co., Ltd. · 2015 · cites it directly0descendants
- K130232Electronic Blood Pressure Monitor for Upper ArmJinxinbao Electronic Co.,Ltd · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −4 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −3 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| −2 | K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2008 | — |
| −1 | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure Monitors | A&D Company, Ltd. | 2011 | — |
| 0 (this device) | K120554 | Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully… | Sejoy Electronics & Instruments Co., Ltd. | 2012 | — |
| +1 | K161577 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2017 | — |
| +1 | K150545 | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307… | Sejoy Electronics & Instruments Co., Ltd. | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsSummary page 5…0 have the same intended use and similar technological characteristics as the A&D Premier Blood Pressure Monitor (Model: UA-1020) whose 5 10 (k) number is KI 111686. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the su… | 2011 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K161577 (Sejoy Electronics & Instruments Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K111686.
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. 2012, 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?
Measure blood pressure (systolic and diastolic) and pulse rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120554: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully Automatic Digital 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/K120554
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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