510(k) · Cleared
ClearedBlood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Transtek Medical Electronics Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 9, 2021 as substantially equivalent to K131395 (Guangdong Transtek Medical Electronics Co., Ltd., 2013) after a 162-day review. Its family tree reaches back 5 generations to 2006. 10 later devices descend from it.
- Decided
- Mar 9, 2021
- Review
- 162 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K061822 (2006). 10 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK061822 Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem…Omron Healthcare, Inc. · 2006
- 4 generations backK101681 Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995Zhongshan Transtek Electronics Co., Ltd. · 2011
- 3 generations backK120058 Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- 2 generations backK123780 Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2013
- 1 generation backK131395 Transtek Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2013
- This deviceK202891 Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK232713 Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK232621 Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK240254 Blood Pressure Monitor (TMB-2296-BT)Guangdong Transtek Medical Electronics Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK250415 G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025
- Descendant · 4 generations on · 0 of its ownK254000 Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K232713Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023 · cites it directly4descendants
- K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023 · cites it directly3descendants
- K240254Blood Pressure Monitor (TMB-2296-BT)Guangdong Transtek Medical Electronics Co., Ltd. · 2024 · 2 generations on2descendants
- K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025 · 3 generations on1descendant
- K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3 | Omron Healthcare, Inc. | 2006 | — |
| −4 | K101681 | Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995 | Zhongshan Transtek Electronics Co., Ltd. | 2011 | — |
| −3 | K120058 | Transtek Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| −2 | K123780 | Transtek Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2013 | — |
| −1 | K131395 | Transtek Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2013 | — |
| 0 (this device) | K202891 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2021 | — |
| +1 | K232713 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023 | — |
| +1 | K232621 | Blood pressure monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023 | — |
| +2 | K240254 | Blood Pressure Monitor (TMB-2296-BT) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024 | — |
| +3 | K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025 | — |
| +4 | K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K131395 | Transtek Blood Pressure MonitorSummary page 4…DXN Submission type Traditional 510(K) 4. Predicate Device 1. Guangdong Transtek Medical Electronics Co., Ltd., TRANSTEK Blood Pressure Monitor under K131395. The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as… | 2013 |
What descends from it? (10)
3 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 15 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232713 (Guangdong Transtek Medical Electronics Co., Ltd., 2023) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K131395.
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. 2021, 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?
The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 45cm (about 8¾"-17½"). The device can be used to detect irregular heartbeat. It is intended for adult indoor use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202891: Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202891
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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