510(k) · Cleared
ClearedWrist-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 Jul 18, 2012 as substantially equivalent to K042967 (A&D Engineering, Inc., 2004) after a 75-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Jul 18, 2012
- Review
- 75 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002115 (2000). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
- 2 generations backK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
- 1 generation backK042967 A&D Medical Lifesource Digital Blood Pressure Monitors, Models…A&D Engineering, Inc. · 2004
- This deviceK121355 Wrist-Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK170666 The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsJoytech Healthcare Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK152426 Wrist - Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd. · 2015
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 | K002115 | A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2000 | — |
| −2 | K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328 | A&D Engineering, Inc. | 2004 | — |
| −1 | K042967 | A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512 | A&D Engineering, Inc. | 2004 | — |
| 0 (this device) | K121355 | Wrist-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2012 | — |
| +1 | K170666 | The Wrist-Type Fully Automatic Digital Blood Pressure Monitors | Joytech Healthcare Co., Ltd. | 2017 | — |
| +1 | K152426 | Wrist - Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K042967 | A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512Summary page 2…=== s E Jo Vr Sejoy Electronics & Instruments Co., Ltd. AM/PM Memory Wrist Blood Pressure Monitor (Model: liD-S12), FDA 510(k) K042967, distributed by A division of A&D Engineering, Inc. 6. Device Description: The wrist-type fully automatic digital… | 2004 |
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 12 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170666 (Joytech Healthcare Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K042967.
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/K121355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121355: 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/K121355
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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