510(k) · Cleared
ClearedArm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-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 Jan 5, 2022 as substantially equivalent to K161886 (Guangdong Transtek Medical Electronics Co., Ltd., 2016) and 2 other predicates after a 182-day review. Its family tree reaches back 6 generations to 2006. 5 later devices descend from it.
- Decided
- Jan 5, 2022
- Review
- 182 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K061822 (2006). 13 ancestors in all, the oldest K003732 (2001). 5 later devices descend from it, 2 citing it directly.
- 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 deviceK212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK230566 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK250548 Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B…Joytech Healthcare Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261394 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186…JOYTECH Healthcare Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253425 Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252501 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B…Joytech Healthcare Co., Ltd. · 2026
Most influential descendants
Showing 5 of 5 · See all- K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2023 · cites it directly2descendants
- K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)Joytech Healthcare Co., Ltd. · 2025 · cites it directly1descendant
- K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…JOYTECH Healthcare Co., Ltd. · 2026 · 2 generations on0descendants
- K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd. · 2026 · 2 generations on0descendants
- K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B…Joytech Healthcare Co., Ltd. · 2026 · 2 generations on0descendants
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) | K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2022 | — |
| +1 | K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2023 | — |
| +1 | K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co., Ltd. | 2025 | — |
| +2 | K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus… | JOYTECH Healthcare Co., Ltd. | 2026 | — |
| +2 | K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor… | Joytech Healthcare Co., Ltd. | 2026 | — |
| +2 | K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B… | Joytech Healthcare Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device…Summary page 5…Monitors are substantially equivalent to the following predicate device: 510(k) number Predicate Product code Manufacturer device model K161886 H-BP100SBP DXN Guangdong Transtek Medical Electronics Co.,… | 2016 |
| * | K182127 | Wrist Blood Pressure Monitor Model BP6100Summary page 5…tors are substantially equivalent to the following prdicate devices: 510(k) number Predicate Product code Manufacturer device model K182127 BP6100 DXN OMRON HEALTHCARE Co., Ltd. K182166 BP4350 DXN OMRON… | 2018 |
| * | K182166 | Wrist Blood Pressure Monitor Model BP4350Summary page 5…umber Predicate Product code Manufacturer device model K182127 BP6100 DXN OMRON HEALTHCARE Co., Ltd. K182166 BP4350 DXN OMRON HEALTHCARE Co., Ltd. 2.5 Device Description: The Arm-type and Wrist-type… | 2018 |
What descends from it? (5)
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 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K230566 (Joytech Healthcare Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K161886.
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. 2022, 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 Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212115: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital 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/K212115
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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