510(k) · Cleared
ClearedA&D Medical UA-851THW Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A&D Engineering, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 13, 2008 as substantially equivalent to K043217 (A&D Engineering, Inc., 2005) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1998. 25 later devices descend from it.
- Decided
- Nov 13, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K982481 (1998). 5 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 2 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 1 generation backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- This deviceK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- Descendant · cites it directly · 13 of its ownK111686 A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011
- Descendant · cites it directly · 10 of its ownK092106 U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure…Taidoc Technology Corporation · 2010
- Descendant · 2 generations on · 5 of its ownK141160 A&D Medical UA-651 Digital Blood Pressure MonitorA & D Co., Ltd. · 2014
- Descendant · 2 generations on · 3 of its ownK120554 Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type…Sejoy Electronics & Instruments Co., Ltd. · 2012
- Descendant · 3 generations on · 2 of its ownK163683 A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure MonitorA&D Company, Ltd. · 2017
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K111686A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011 · cites it directly13descendants
- K092106U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor, Model TD-3132…Taidoc Technology Corporation · 2010 · cites it directly10descendants
- K141160A&D Medical UA-651 Digital Blood Pressure MonitorA & D Co., Ltd. · 2014 · 2 generations on5descendants
- K120554Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully Automatic…Sejoy Electronics & Instruments Co., Ltd. · 2012 · 2 generations on3descendants
- K163683A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure MonitorA&D Company, Ltd. · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −2 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −1 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| 0 (this device) | 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 | — |
| +1 | K092106 | U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor… | Taidoc Technology Corporation | 2010 | — |
| +2 | K141160 | A&D Medical UA-651 Digital Blood Pressure Monitor | A & D Co., Ltd. | 2014 | — |
| +2 | K120554 | Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully… | Sejoy Electronics & Instruments Co., Ltd. | 2012 | — |
| +3 | K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | A&D Company, Ltd. | 2017 | — |
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 |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K043217 | A&D Medical UA-767PBT Digital Blood Pressure MonitorSummary page 1…5. PREDICATE DEVICE A&D LifeSource model UA-767PBT digital blood pressure monitor with FDA 5 10(k) K043217 A&D LifeSource model UA-789 digital blood pressure monitor with FDA 510(k) K062027.… | 2005 |
| * | K062027 | A&D Medical UA-789 Digital Blood Pressure MonitorSummary page 1…with FDA 5 10(k) K043217 A&D LifeSource model UA-789 digital blood pressure monitor with FDA 510(k) K062027. Both devices are designed and manufactured by the same company and facility as the… | 2007 |
What descends from it? (25)
See all 252 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 10 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K111686 (A&D Company, Ltd., 2011) has gone furthest, with 13 descendants of its own.
- 11 other devices also cite its predicate K043217.
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. 2008, 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/K082734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082734: A&D Medical UA-851THW 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/K082734
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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