510(k) · Cleared
ClearedFull Auto Wrist Digital Blood Pressure Monitor Model# SE-311
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sein Electronics Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 24, 2004 as substantially equivalent to K012054 (Sein Electronics Co., Ltd., 2001) after a 15-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Aug 24, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012054 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK012054 Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312Sein Electronics Co., Ltd. · 2001
- This deviceK042138 Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311Sein Electronics Co., Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK052108 Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK080853 Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK080636 Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd. · 2009
Most influential descendants
Showing 3 of 3 · See all- K052108Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005 · cites it directly2descendants
- K080853Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009 · 2 generations on0descendants
- K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012054 | Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312 | Sein Electronics Co., Ltd. | 2001 | — |
| 0 (this device) | K042138 | Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311 | Sein Electronics Co., Ltd. | 2004 | — |
| +1 | K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 | Sein Electronics Co., Ltd. | 2005 | — |
| +2 | K080853 | Duo-Care Blood Glucose and Blood Pressure Monitor System | Genexel-Sein, Inc. | 2009 | — |
| +2 | K080636 | Duo-Max Blood Pressure & Glucose Monitor HMF-100 | Hubdic Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K012054 | Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312Summary page 1…med against the following device: Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312, manufactured by Sein Electronics Co., Ltd. 510Ok #K01 2054 16- Description of the Device: Full Auto Wrist Digital Blood Pressure Monitor SE-311I is intended to measure systolic and dias… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 | 2005 | 2 |
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?
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.
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?
This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042138: Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042138
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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