510(k) · Cleared
ClearedFull Auto Arm Digital Blood Pressure Monitor
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 May 7, 2004 as substantially equivalent to K003282 (Sein Electronics Co., Ltd., 2000) after a 228-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- May 7, 2004
- Review
- 228 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003282 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003282 Full Auto Blood Pressure Monitor, Model SE-7700HSein Electronics Co., Ltd. · 2000
- This deviceK032927 Full Auto Arm Digital Blood Pressure MonitorSein Electronics Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK042014 Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400Sein Electronics Co., Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042014Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400Sein Electronics Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003282 | Full Auto Blood Pressure Monitor, Model SE-7700H | Sein Electronics Co., Ltd. | 2000 | — |
| 0 (this device) | K032927 | Full Auto Arm Digital Blood Pressure Monitor | Sein Electronics Co., Ltd. | 2004 | — |
| +1 | K042014 | Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400 | Sein Electronics Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K003282 | Full Auto Blood Pressure Monitor, Model SE-7700HSummary page 2…ched. Indeed, this device is SIMILAR to the predicate device. FDA file reference number 5 10k # K003282 Attachments inside notification submission file 5 10k sumnmary print out TECHN… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042014 | Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400 | 2004 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K042014 (Sein Electronics Co., Ltd., 2004) has gone furthest, with 0 descendants of its own.
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/K032927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032927: Full Auto Arm 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/K032927
Report an extraction error
Are you the manufacturer?
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