510(k) · Cleared
ClearedA&D Medical UA-651 Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A & D Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 7, 2014 as substantially equivalent to K111686 (A&D Company, Ltd., 2011) and 1 other predicate after a 155-day review. Its family tree reaches back 5 generations to 1998. 5 later devices descend from it.
- Decided
- Oct 7, 2014
- Review
- 155 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K982481 (1998). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 4 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 3 generations backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- 2 generations backK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- 1 generation backK111686 A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011
- This deviceK141160 A&D Medical UA-651 Digital Blood Pressure MonitorA & D Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK163683 A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure MonitorA&D Company, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK231984 Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK220220 Electronic Sphygmomanometer (Model: LT-P30)Zhuhai Linte Medical Instrument Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK251307 Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK241007 Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)Shenzhen Urion Technology Co., Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K163683A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure MonitorA&D Company, Ltd. · 2017 · cites it directly2descendants
- K231984Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2024 · 2 generations on1descendant
- K220220Electronic Sphygmomanometer (Model: LT-P30)Zhuhai Linte Medical Instrument Co., Ltd. · 2022 · cites it directly1descendant
- K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026 · 3 generations on0descendants
- K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)Shenzhen Urion 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 |
|---|---|---|---|---|---|
| −5 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −4 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −3 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| −2 | K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2008 | — |
| −1 | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure Monitors | A&D Company, Ltd. | 2011 | — |
| 0 (this device) | K141160 | A&D Medical UA-651 Digital Blood Pressure Monitor | A & D Co., Ltd. | 2014 | — |
| +1 | K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | A&D Company, Ltd. | 2017 | — |
| +2 | K231984 | Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2024 | — |
| +1 | K220220 | Electronic Sphygmomanometer (Model: LT-P30) | Zhuhai Linte Medical Instrument Co., Ltd. | 2022 | — |
| +3 | K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026 | — |
| +2 | K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Shenzhen Urion Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsSummary page 4…21 CFR 870.1130, Class II, 74DXN. 4. Predicate Devices A&D Model UA-1000 Family Digital Blood Pressure Monitors with 510(k) number K111686 A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 Predicate devices are designed and ma… | 2011 |
| * | K043217 | A&D Medical UA-767PBT Digital Blood Pressure MonitorSummary page 4…A&D Model UA-1000 Family Digital Blood Pressure Monitors with 510(k) number K111686 A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 Predicate devices are designed and manufactured by the same company and facilities as the modified devices UA-651.… | 2005 |
What descends from it? (5)
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)
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 16 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K163683 (A&D Company, Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K111686.
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. 2014, 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?
Measure blood pressure (systolic and diastolic) and pulse rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141160: A&D Medical UA-651 Digital 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/K141160
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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