510(k) · Cleared
ClearedTranstek 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 Jan 31, 2012 as substantially equivalent to K101681 (Zhongshan Transtek Electronics Co., Ltd., 2011) after a 22-day review. Its family tree reaches back 2 generations to 2006. 20 later devices descend from it.
- Decided
- Jan 31, 2012
- Review
- 22 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061822 (2006). 20 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK061822 Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem…Omron Healthcare, Inc. · 2006
- 1 generation backK101681 Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995Zhongshan Transtek Electronics Co., Ltd. · 2011
- This deviceK120058 Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- Descendant · cites it directly · 19 of its ownK123780 Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2013
- Descendant · 2 generations on · 18 of its ownK131395 Transtek Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2013
- Descendant · 3 generations on · 10 of its ownK202891 Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2021
- Descendant · 3 generations on · 7 of its ownK161886 Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood…Guangdong Transtek Medical Electronics Co., Ltd. · 2016
- Descendant · 4 generations on · 5 of its ownK212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K123780Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2013 · cites it directly19descendants
- K131395Transtek Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2013 · 2 generations on18descendants
- K202891Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2021 · 3 generations on10descendants
- K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device…Guangdong Transtek Medical Electronics Co., Ltd. · 2016 · 3 generations on7descendants
- K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2022 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3 | Omron Healthcare, Inc. | 2006 | — |
| −1 | K101681 | Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995 | Zhongshan Transtek Electronics Co., Ltd. | 2011 | — |
| 0 (this device) | K120058 | Transtek Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| +1 | K123780 | Transtek Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2013 | — |
| +2 | K131395 | Transtek Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2013 | — |
| +3 | K202891 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2021 | — |
| +3 | K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure… | Guangdong Transtek Medical Electronics Co., Ltd. | 2016 | — |
| +4 | K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K101681 | Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995Summary page 1…ications: Do not use the Analyzer if you have a pacemaker or other internal medical device. 4. The Predicate Devices TRANSTEK, Blood Pressure Monitor, Model TMB-986, K101681 Section 5 -510(k) Summary 'age I of'5 TRRN… | 2011 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123780 | Transtek Blood Pressure Monitor | 2013 | 19 |
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 6 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123780 (Zhongshan Transtek Electronics Co., Ltd., 2013) has gone furthest, with 19 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. 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 arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).
These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood, pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Blood Pressure Monitor, LS-802, TMB-lO0 18, TMB- 101 8-A, TM B-l 12, and TMB-I 112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indlkated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120058 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120058: Transtek 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/K120058
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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