510(k) · Cleared
ClearedA & D Medical UA-767BT 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 May 19, 2004 as substantially equivalent to K982481 (A&D Engineering, Inc., 1998) after a 92-day review. Its family tree reaches back 1 generation to 1998. 86 later devices descend from it.
- Decided
- May 19, 2004
- Review
- 92 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982481 (1998). 86 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- This deviceK040371 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 · cites it directly · 16 of its ownK072137 Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZBAvita Corporation · 2007
- Descendant · cites it directly · 15 of its ownK121025 YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor…Ya Horng Electronic Co., Ltd. · 2012
- Descendant · 2 generations on · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- 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 · cites it directly16descendants
- K121025YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth TransmissionYa Horng Electronic Co., Ltd. · 2012 · cites it directly15descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| 0 (this device) | 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 | — |
| +1 | K072137 | Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZB | Avita Corporation | 2007 | — |
| +1 | K121025 | YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth… | Ya Horng Electronic Co., Ltd. | 2012 | — |
| +2 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K982481 | A&D Medical UA-767PC Digital Blood Pressure MonitorSummary page 1…5. PREDICATE DEVCIE It is substantially equivalent to the following device: A&D UA-767PC, FDA 510(k) K982481. Issued on Jan. 13, 1999 6. TECHNOLOGICAL CHARACTERISTECS UA-767BT uses an inflated… | 1998 |
What descends from it? (86)
See all 865 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | 2005 | 49 |
| K072137 | Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZB | 2007 | 16 |
| K121025 | YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth Transmission | 2012 | 15 |
| K083681 | Bioland Blood Pressure Monitor | 2009 | 1 |
| K131788 | Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application… | 2014 | 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?
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-767BT is designed to be used by end users who are eighteen (18) years and older at home 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-767BT memory. UA-767BT through its Bluetooth wireless communication port can also transfer the measurements stored in memory to other electronic devices, such as an Access Point, PC, a modem, or a printer. The end user…
Read the full statement (125 words)
The UA-767BT is designed to be used by end users who are eighteen (18) years and older at home 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-767BT memory. UA-767BT through its Bluetooth wireless communication port can also transfer the measurements stored in memory to other electronic devices, such as an Access Point, 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-767BT uses the oscillometric method to conduct the measurement. It 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 as stated in the FDA summary.
https://510kreport.com/device/K040371 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040371: A & D Medical UA-767BT Digital Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040371
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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