510(k) · Cleared
ClearedU80 Series Upper Arm Electronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Urion Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 22, 2016 as substantially equivalent to K001670 (Omron Healthcare, Inc., 2000) after a 108-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.
- Decided
- Apr 22, 2016
- Review
- 108 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001670 (2000). 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- This deviceK160019 U80 Series Upper Arm Electronic Blood Pressure MonitorShenzhen Urion Technology Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK243115 Upper Arm Electronic Blood Pressure Monitor (U87Y series (models…Shenzhen Urion Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK241129 Upper Arm Electronic Blood Pressure MonitorShenzhen Goodlymed Technology Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK220886 Upper Arm Type Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK260273 Automatic Electronic Blood Pressure Monitor (U90B series models…Shenzhen Urion Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243118 Arm Blood Pressure Monitor (model: BPM-A7VL)Shenzhen Imdk Medical Technology Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K243115Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y…Shenzhen Urion Technology Co., Ltd. · 2025 · cites it directly1descendant
- K241129Upper Arm Electronic Blood Pressure MonitorShenzhen Goodlymed Technology Co., Ltd. · 2024 · cites it directly1descendant
- K220886Upper Arm Type Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd. · 2022 · cites it directly1descendant
- K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B…Shenzhen Urion Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K243118Arm Blood Pressure Monitor (model: BPM-A7VL)Shenzhen Imdk Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| 0 (this device) | K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | Shenzhen Urion Technology Co., Ltd. | 2016 | — |
| +1 | K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including… | Shenzhen Urion Technology Co., Ltd. | 2025 | — |
| +1 | K241129 | Upper Arm Electronic Blood Pressure Monitor | Shenzhen Goodlymed Technology Co., Ltd. | 2024 | — |
| +1 | K220886 | Upper Arm Type Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | 2022 | — |
| +2 | K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including (… | Shenzhen Urion Technology Co., Ltd. | 2026 | — |
| +2 | K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Summary page 6…at home. The intended upper arm circumference is 22-36 cm. Suitable for p e r s o n s who over the age of 12. 5. Predicate Device Identification 510(k) Number: K001670 Product Name: Electronic Blood Pressure Monitor, HEM-757 Manufacturer: Omron Healthcare, Inc 6. Device Description… | 2000 |
What descends from it? (7)
4 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?
The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160019: U80 Series Upper Arm Electronic 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/K160019
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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