510(k) · Cleared
ClearedNon-invasive blood pressure measurement systems
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 22, 2018 after a 328-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Aug 22, 2018
- Review
- 328 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK173024 Non-invasive blood pressure measurement systemsJoytech Healthcare Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK213189 Wrist-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK200649 Arm-Type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK190886 Non-invasive blood pressure measurement systemsJoytech Healthcare Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd. · 2022 · cites it directly0descendants
- K200649Arm-Type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd. · 2020 · cites it directly0descendants
- K190886Non-invasive blood pressure measurement systemsJoytech Healthcare Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K173024 | Non-invasive blood pressure measurement systems | Joytech Healthcare Co., Ltd. | 2018 | — |
| +1 | K213189 | Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co., Ltd. | 2022 | — |
| +1 | K200649 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co., Ltd. | 2020 | — |
| +1 | K190886 | Non-invasive blood pressure measurement systems | Joytech Healthcare Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
3 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?
- Of its descendants, K213189 (Joytech Healthcare Co., Ltd., 2022) has gone furthest, with 0 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. 2018, 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 | — |
https://510kreport.com/device/K173024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173024: Non-invasive blood pressure measurement systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173024
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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