510(k) · Cleared
ClearedTranstek Wrist Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhongshan Transtek Electronics Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 22, 2012 as substantially equivalent to K042505 (Omron Healthcare, Inc., 2005) after a 69-day review. Its family tree reaches back 1 generation to 2005. 5 later devices descend from it.
- Decided
- Oct 22, 2012
- Review
- 69 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042505 (2005). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- This deviceK122482 Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK123669 Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK150908 XM-01 Electronic Automatic Blood Pressure MonitorSky Innovation Technology ( Shanghai) Limited · 2015
- Descendant · 2 generations on · 0 of its ownK233130 Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK222394 Electronic SphygmomanometersQingdao Yasee Medical Device Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK202599 Transtek Wrist Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K123669Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012 · cites it directly4descendants
- K150908XM-01 Electronic Automatic Blood Pressure MonitorSky Innovation Technology ( Shanghai) Limited · 2015 · 2 generations on1descendant
- K233130Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023 · 2 generations on0descendants
- K222394Electronic SphygmomanometersQingdao Yasee Medical Device Co., Ltd. · 2023 · 3 generations on0descendants
- K202599Transtek Wrist Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| 0 (this device) | K122482 | Transtek Wrist Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| +1 | K123669 | Transtek Wrist Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| +2 | K150908 | XM-01 Electronic Automatic Blood Pressure Monitor | Sky Innovation Technology ( Shanghai) Limited | 2015 | — |
| +2 | K233130 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023 | — |
| +3 | K222394 | Electronic Sphygmomanometers | Qingdao Yasee Medical Device Co., Ltd. | 2023 | — |
| +2 | K202599 | Transtek Wrist Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NSummary page 1…de: DXN Device Classification: Class 11 Contraindications: None 4. The Predicate Devices OMRON, DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N, K042505 Sctioni 5 0(k) Sumnmary 1/5 5. lDevice Description Transtek Wrist Blood Pressure Mo… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123669 | Transtek Wrist Blood Pressure Monitor | 2012 | 4 |
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. 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?
This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4-8 1/2 inches). This series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American…
Read the full statement (102 words)
This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4-8 1/2 inches).
This series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122482: Transtek Wrist 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/K122482
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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