510(k) · Cleared
ClearedAGE Automatic Wrist 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 K151281 (Dongguan Ageless Health Industrial Co., Ltd., 2015) after a 199-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Jul 12, 2020
- Review
- 199 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002115 (2000). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
- 4 generations backK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
- 3 generations backK042967 A&D Medical Lifesource Digital Blood Pressure Monitors, Models…A&D Engineering, Inc. · 2004
- 2 generations backK130564 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- 1 generation backK151281 AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015
- This deviceK193628 AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK213503 Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK250161 Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor…Shenzhen AOJ Medical Technology Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See all- K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd. · 2022 · cites it directly1descendant
- K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist…Shenzhen AOJ Medical 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 |
|---|---|---|---|---|---|
| −5 | K002115 | A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2000 | — |
| −4 | K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328 | A&D Engineering, Inc. | 2004 | — |
| −3 | K042967 | A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512 | A&D Engineering, Inc. | 2004 | — |
| −2 | K130564 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| −1 | K151281 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan Ageless Health Industrial Co., Ltd. | 2015 | — |
| 0 (this device) | K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020 | — |
| +1 | K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +2 | K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor… | Shenzhen AOJ Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K151281 | AGE Automatic Wrist Blood Pressure MonitorSummary page 4…Device Name and Model Models: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613 510(k) Number K151281 Product Code DXN Regulation Number 870.1130 Report by DONGGUAN E-TEST TECHNOLOGY CO., LTD… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | 2022 | 1 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K213503 (Shenzhen AOJ Medical Technology Co., Ltd., 2022) has gone furthest, with 1 descendant 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. 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 Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.
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/K193628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193628: AGE Automatic Wrist Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193628
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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