510(k) · Cleared
ClearedBlood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202
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 Apr 3, 2008 as substantially equivalent to K042418 (Kodon (Tianjin)Electronic&Electrical Apparatus Co.,, 2005) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 3, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001670 (2000). 5 ancestors in all, the oldest K001671 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 2 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 1 generation backK042418 KD-575 Memory Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2005
- This deviceK080789 Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202Sejoy Electronics & Instruments Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −2 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −1 | K042418 | KD-575 Memory Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2005 | — |
| 0 (this device) | K080789 | Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202 | Sejoy Electronics & Instruments Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K042418 | KD-575 Memory Automatic Electronic Blood Pressure MonitorSummary page 1…Predicate Device Information: For submitted devices BP-] 02 and BP-] 03 : *Memory Automatic Electronic Blood Pressure Monitor (Model: KD-575) 5 10(k) number: K0424 18 Applicant: KODON (TIANJIN) ELECTRON IC&ELECTFRICALAPPARATLJS CO. Owner: KODON (TIANJ IN) ELECTRON IC&ELECTRICA LAPPA R… | 2005 |
| * | K030359 | KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorSummary page 1…ECTRICA LAPPA RATLUS CO. For submitted devices BP-201 and BP-202: *Memory Wrist Automatic Electronic Blood Pressure Monitor (Model: KD-726) 5 10(k) number: K030359 Applicant: KODON (TIANJIN) ELECTRON IC&ELECTRICAL APPARATUS CO. Owner: KODON (TIANJ IN) ELECTRON IC&ELECTRICAL APPA… | 2003 |
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 8 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K042418.
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. 2008, 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 model BP series are designed to measure the systolic. diastolic pressure and pulse rate of people by using (? non-invasive technique. which is a well-known technique in the market called ihe "oscillometric method".
BP-102 and BP-103 are the arm-type Blood Pressure Monitors. which can measure the systolic, diastolic pressure and pulse rate at upper-arm. and BP-201 and BP-202 are the wrist-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at wrist. and the devices are reusable for clinical and home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080789 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080789: Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080789
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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