510(k) · Cleared
Recalled · Class II · 2024Automatic Upper Arm Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan E-Test Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 12, 2020 as substantially equivalent to K153552 (Ageless Health Industrial Co., Ltd., 2016) and 1 other predicate after a 199-day review. Its family tree reaches back 3 generations to 2013. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 12, 2020
- Review
- 199 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K123882 (2013). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK123882 Age Automatic Upper Arm Blood Pressure MonitorAgeless Health Industrial · 2013
- 2 generations backK153552 AGE Automatic Upper Arm Blood Pressure MonitorAgeless Health Industrial Co., Ltd. · 2016
- 1 generation backK172895 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815…Ageless Health Industrial Co., Ltd. · 2018
- This deviceK193627 Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK222926 Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure…Shenzhen Yuezhongxing Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250231 Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X…Dongguan E-Test Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK241590 Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07…Guangdong Xinyu Electronic and Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K222926Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name…Shenzhen Yuezhongxing Technology Co., Ltd. · 2023 · cites it directly1descendant
- K250231Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X…Dongguan E-Test Technology Co., Ltd. · 2025 · cites it directly0descendants
- K241590Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)Guangdong Xinyu Electronic and Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K123882 | Age Automatic Upper Arm Blood Pressure Monitor | Ageless Health Industrial | 2013 | — |
| −2 | K153552 | AGE Automatic Upper Arm Blood Pressure Monitor | Ageless Health Industrial Co., Ltd. | 2016 | — |
| −1 | K172895 | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816… | Ageless Health Industrial Co., Ltd. | 2018 | — |
| 0 (this device) | K193627 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020 | — |
| +1 | K222926 | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model… | Shenzhen Yuezhongxing Technology Co., Ltd. | 2023 | — |
| +1 | K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X… | Dongguan E-Test Technology Co., Ltd. | 2025 | — |
| +2 | K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08… | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K153552 | AGE Automatic Upper Arm Blood Pressure MonitorSummary page 6…2 Page 2 of 11 K193627 510(k) Number K153552 K172895 Product Code DXN DXN… | 2016 |
| * | K172895 | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and…Summary page 6…2 Page 2 of 11 K193627 510(k) Number K153552 K172895 Product Code DXN DXN Regulation 870.1130… | 2018 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2024 | Class II | Z-0032-2025 | Under Investigation by firm | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the… |
| Aug 30, 2024 | Class II | Z-0034-2025 | Under Investigation by firm | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the… |
| Aug 30, 2024 | Class II | Z-0033-2025 | Under Investigation by firm | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the… |
| Feb 26, 2024 | Class II | Z-1459-2024 | Nonconforming Material/Component | The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K222926 (Shenzhen Yuezhongxing Technology Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K153552.
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?
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
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/K193627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193627: Automatic Upper Arm 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/K193627
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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