510(k) · Cleared
ClearedA&D Medical UA-767PC 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 Sep 25, 1998 after a 71-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 103 later devices descend from it.
- Decided
- Sep 25, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
103 later devices descend from it, 6 citing it directly.
- This deviceK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- Descendant · cites it directly · 86 of its ownK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- Descendant · cites it directly · 49 of its ownK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 25 of its ownK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- Descendant · 2 generations on · 16 of its ownK072137 Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZBAvita Corporation · 2007
- Descendant · 2 generations on · 15 of its ownK121025 YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor…Ya Horng Electronic Co., Ltd. · 2012
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K040371A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004 · cites it directly86descendants
- K043217A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · cites it directly49descendants
- K082734A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008 · 2 generations on25descendants
- K072137Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZBAvita Corporation · 2007 · 2 generations on16descendants
- K121025YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth TransmissionYa Horng Electronic Co., Ltd. · 2012 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| +1 | 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 |
| +2 | K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2008 | — |
| +2 | K072137 | Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZB | Avita Corporation | 2007 | — |
| +2 | K121025 | YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth… | Ya Horng Electronic Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (103)
See all 1036 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | 2004 | 86 |
| K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | 2005 | 49 |
| K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors | 2003 | 8 |
| K053304 | Commander Iii Non-Invasive Blood Pressure System | 2005 | 6 |
| K051546 | Bpcalibrator MC3000/MC3100 | 2005 | 3 |
| K083078 | Quanta Blood Pressure Meter, Model: Cardiac Elite 1000 or QH200 | 2008 | 0 |
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?
- Of its descendants, K040371 (A&D Engineering, Inc., 2004) has gone furthest, with 86 descendants 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.
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 UA-767PC is designed to be used by end users who are eighteen (18) years and older at home and doctor/nurse office to monitor their blood pressure (systolic and diastolic) and pulse rate. At the end of each measurement, the results will be stored in the UA-767PC memory. UA-T67PC through its communication port can also transfer the measurements stored in ety (0 other electronic devices, such as a PC, a modem, or a printer. The end user should not have…
Read the full statement (125 words)
The UA-767PC is designed to be used by end users who are eighteen (18) years and older at home and doctor/nurse office to monitor their blood pressure (systolic and diastolic) and pulse rate. At the end of each measurement, the results will be stored in the UA-767PC memory. UA-T67PC through its communication port can also transfer the measurements stored in ety (0 other electronic devices, such as a PC, a modem, or a printer. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation, UA-767PC uses the oscillometric method to conduct the measurement. Tt is not designed for ambulatory use. The arm circumference range shall be between 5 1 inches (13.0 cm) to 17.7 inches (45.0 ¢cm).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982481: A&D Medical UA-767PC 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/K982481
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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