510(k) · Cleared
ClearedAGE Automatic Upper Arm Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ageless Health Industrial Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 1, 2016 as substantially equivalent to K123882 (Ageless Health Industrial, 2013) after a 173-day review. Its family tree reaches back 1 generation to 2013. 8 later devices descend from it.
- Decided
- Jun 1, 2016
- Review
- 173 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123882 (2013). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK123882 Age Automatic Upper Arm Blood Pressure MonitorAgeless Health Industrial · 2013
- This deviceK153552 AGE Automatic Upper Arm Blood Pressure MonitorAgeless Health Industrial Co., Ltd. · 2016
- Descendant · cites it directly · 6 of its ownK172895 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815…Ageless Health Industrial Co., Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK193627 Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK222926 Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure…Shenzhen Yuezhongxing Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK250231 Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X…Dongguan E-Test Technology Co., Ltd. · 2025
- Descendant · 3 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172895AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and…Ageless Health Industrial Co., Ltd. · 2018 · cites it directly6descendants
- K193627Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020 · cites it directly3descendants
- K222926Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name…Shenzhen Yuezhongxing Technology Co., Ltd. · 2023 · 2 generations on1descendant
- K250231Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X…Dongguan E-Test Technology Co., Ltd. · 2025 · 2 generations on0descendants
- 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 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123882 | Age Automatic Upper Arm Blood Pressure Monitor | Ageless Health Industrial | 2013 | — |
| 0 (this device) | 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 | — |
| +1 | K193627 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020 | 4 |
| +2 | K222926 | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model… | Shenzhen Yuezhongxing Technology Co., Ltd. | 2023 | — |
| +2 | K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X… | Dongguan E-Test Technology Co., Ltd. | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K123882 | Age Automatic Upper Arm Blood Pressure MonitorSummary page 5…Name: Noninvasive blood pressure measurement systems Trade Name: AGE Automatic Upper Arm Blood Pressure Monitor 510(k) number: K123882 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 21 CFR 870.1130 Regulation Cl… | 2013 |
What descends from it? (8)
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?
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. 2016, 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?
AGE Automatic Upper Arm 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 upper arm. The cuff circumference is six sizes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153552: AGE 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/K153552
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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