510(k) · Cleared
ClearedYA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth Transmission
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ya Horng Electronic Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 17, 2012 as substantially equivalent to K090058 (Ya Horng Electronic Co., Ltd., 2009) and 1 other predicate after a 135-day review. Its family tree reaches back 5 generations to 2000. 15 later devices descend from it.
- Decided
- Aug 17, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001182 (2000). 7 ancestors in all, the oldest K982481 (1998). 15 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK001182 Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp. · 2000
- 4 generations backK012796 Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002
- 3 generations backK051862 PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U…Ya Horng Electronic Co., Ltd. · 2005
- 2 generations backK072860 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J…Ya Horng Electronic Co., Ltd. · 2008
- 1 generation backK090058 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T…Ya Horng Electronic Co., Ltd. · 2009
- This deviceK121025 YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor…Ya Horng Electronic Co., Ltd. · 2012
- Descendant · cites it directly · 8 of its ownK140067 QardioarmQardio, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK161846 Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016
- Descendant · 3 generations on · 4 of its ownK171833 Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK192023 Arm Blood Pressure MonitorTruly Instrument Limited · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K140067QardioarmQardio, Inc. · 2014 · cites it directly8descendants
- K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015 · 2 generations on6descendants
- K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016 · cites it directly5descendants
- K171833Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018 · 3 generations on4descendants
- K192023Arm Blood Pressure MonitorTruly Instrument Limited · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001182 | Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 | Microlife Corp. | 2000 | — |
| −4 | K012796 | Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000 | Amluck, Inc. | 2002 | — |
| −3 | K051862 | PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R… | Ya Horng Electronic Co., Ltd. | 2005 | — |
| −2 | K072860 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −1 | K090058 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U… | Ya Horng Electronic Co., Ltd. | 2009 | — |
| 0 (this device) | K121025 | YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth… | Ya Horng Electronic Co., Ltd. | 2012 | — |
| +1 | K140067 | Qardioarm | Qardio, Inc. | 2014 | — |
| +2 | K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | Fudakang Industrial Co., Ltd. | 2015 | — |
| +1 | K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | Truly Instrument Limited | 2016 | — |
| +3 | K171833 | Digital Blood Pressure Monitor-Wrist Style | Shenzhen Combei Technology Co., Ltd. | 2018 | — |
| +2 | K192023 | Arm Blood Pressure Monitor | Truly Instrument Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K090058 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B…Summary page 1…e (Predicate) Device: Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB (K090058) * A & D Medical UA-767BT Digital Blood Pressure Monitor (K040371)… | 2009 |
| * | K040371 | A & D Medical UA-767BT Digital Blood Pressure MonitorSummary page 1…and BP-700TUB (K090058) * A & D Medical UA-767BT Digital Blood Pressure Monitor (K040371) El… | 2004 |
| † | K055139 | YA HORNG Blood-Pressure Cuff |
What descends from it? (15)
See all 152 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 12 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K140067 (Qardio, Inc., 2014) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K090058.
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?
The YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9.0"-13.0" for Arm type.
Optional model: BP-700W with Bluetooth module for the wireless communication function connects to the PC for record archiving and printing purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121025: YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth Transmission.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121025
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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