510(k) · Cleared
ClearedDisital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Seimitsu Sokki Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 2, 2012 as substantially equivalent to K993890 (Nihon Seimitsu Sokki Co., Ltd., 1999) and 3 other predicates after a 329-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Aug 2, 2012
- Review
- 329 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K850316 (1985). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 5 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 4 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 3 generations backK071384 Modification to: Digital Blood Pressure Monitor, Model 1901Nihon Seimitsu Sokki Co., Ltd. · 2007
- 2 generations backK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
- 1 generation backK112691 Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2012
- This deviceK112620 Disital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −5 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −4 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −3 | K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901 | Nihon Seimitsu Sokki Co., Ltd. | 2007 | — |
| −2 | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −1 | K112691 | Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2012 | — |
| 0 (this device) | K112620 | Disital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K993890 | Digital Blood Pressure Monitor, Model DS-181Summary page 1…e monitor Classification: Noninvasive blood pressure measurement system, DXN, 870.1130, Class 11 (3) Predicate devices: Model DS-181 Digital Blood Pressure Monitor, K993890/Model DSK-l0ll Blood Pressure Monitor, KI 12691/Wrist Blood Pressure Monitor, Model WS-l l00/WS-1l0OPV, K080 177 manuf… | 1999 |
| * | K112691 | Blood Pressure Monitor Cleared while this submission was under review | 2012 |
| * | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVSummary page 1…vices: Model DS-181 Digital Blood Pressure Monitor, K993890/Model DSK-l0ll Blood Pressure Monitor, KI 12691/Wrist Blood Pressure Monitor, Model WS-l l00/WS-1l0OPV, K080 177 manufactured by Nohon Seimitsu Sokki Co., Ltd. and Model HEM-789N3/BP7851BP760 Blood Pressure Mo… | 2008 |
| * | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3Summary page 1…l WS-l l00/WS-1l0OPV, K080 177 manufactured by Nohon Seimitsu Sokki Co., Ltd. and Model HEM-789N3/BP7851BP760 Blood Pressure Monitor, K06 1822 manufactured by OMRON HEALTHCARE Co., Ltd. (4) Description of the device: Blood Pressure Monitor DSK-1031 is an automatic… | 2006 |
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 27 years and passes through 1 company; a new generation was cleared every 3.8 years on median.
- None of the 11 ancestors has a recall.
- 3 other devices also cite its predicate K993890.
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?
Blood Pressure Monitor DSK-1031 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112620: Disital 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/K112620
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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