510(k) · Cleared
ClearedTranstek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
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 Oct 14, 2016 as substantially equivalent to K131395 (Guangdong Transtek Medical Electronics Co., Ltd., 2013) after a 95-day review. Its family tree reaches back 5 generations to 2006. 7 later devices descend from it.
- Decided
- Oct 14, 2016
- Review
- 95 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K061822 (2006). 7 later devices descend from it, 2 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 deviceK161886 Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood…Guangdong Transtek Medical Electronics Co., Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK230566 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK250548 Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B…Joytech Healthcare Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK261394 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186…JOYTECH Healthcare Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK253425 Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2022 · cites it directly5descendants
- K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2023 · 2 generations on2descendants
- K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)Joytech Healthcare Co., Ltd. · 2025 · 2 generations on1descendant
- K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…JOYTECH Healthcare Co., Ltd. · 2026 · 3 generations on0descendants
- K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd. · 2026 · 3 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) | K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure… | Guangdong Transtek Medical Electronics Co., Ltd. | 2016 | — |
| +1 | K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2022 | — |
| +2 | K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2023 | — |
| +2 | K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co., Ltd. | 2025 | — |
| +3 | K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus… | JOYTECH Healthcare Co., Ltd. | 2026 | — |
| +3 | K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor… | Joytech Healthcare Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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…on/Usual Name: Arm Blood Pressure Monitor Product Code: DXN Device Classification: ClassⅡ 3. The Predicate Devices TRANSTEK, Blood Pressure Monitor, Model TMB-1018-BT, K131395 4. Device Description Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-… | 2013 |
What descends from it? (7)
2 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 10 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, K212115 (Joytech Healthcare Co., Ltd., 2022) has gone furthest, with 5 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. 2016, 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?
Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 15 cm to 54 cm (about 6-21 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. Contraindications: This device is…
Read the full statement (104 words)
Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 15 cm to 54 cm (about 6-21 inches).
These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
Contraindications:
This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.
These device are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
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/K161886 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161886: Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161886
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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