510(k) · Cleared
ClearedArm-Type Fully Automatic Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joytech Healthcare Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 3, 2020 as substantially equivalent to K173024 (Joytech Healthcare Co., Ltd., 2018) and 1 other predicate after a 144-day review. Its family tree reaches back 6 generations to 2006.
- Decided
- Aug 3, 2020
- Review
- 144 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K061822 (2006). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK061822 Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem…Omron Healthcare, Inc. · 2006
- 5 generations backK101681 Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995Zhongshan Transtek Electronics Co., Ltd. · 2011
- 4 generations backK120058 Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- 3 generations backK123780 Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2013
- 2 generations backK131395 Transtek Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. · 2013
- 1 generation backK161886 Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood…Guangdong Transtek Medical Electronics Co., Ltd. · 2016
- This deviceK200649 Arm-Type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3 | Omron Healthcare, Inc. | 2006 | — |
| −5 | K101681 | Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995 | Zhongshan Transtek Electronics Co., Ltd. | 2011 | — |
| −4 | K120058 | Transtek Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| −3 | K123780 | Transtek Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2013 | — |
| −2 | K131395 | Transtek Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2013 | — |
| −1 | K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure… | Guangdong Transtek Medical Electronics Co., Ltd. | 2016 | — |
| 0 (this device) | K200649 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K173024 | Non-invasive blood pressure measurement systemsSummary page 4…Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following devices: 510(k) number model Product code Manufacturer K173024 DBP-1307 DXN JOYTECH HEALTHCARE CO., LTD. K161886 H-BP100SBP DXN Guangdong… | 2018 |
| * | K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device…Summary page 4…o the following devices: 510(k) number model Product code Manufacturer K173024 DBP-1307 DXN JOYTECH HEALTHCARE CO., LTD. K161886 H-BP100SBP DXN Guangdong Transtek Medical Electronics… | 2016 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K173024.
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. 2020, 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 Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200649 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200649: Arm-Type Fully Automatic Digital 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/K200649
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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