510(k) · Cleared
Recalled · Class II · 2016A&D Medical UA-767PBT 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 Mar 3, 2005 as substantially equivalent to K982481 (A&D Engineering, Inc., 1998) and 2 other predicates after a 101-day review. Its family tree reaches back 2 generations to 1998. 49 later devices descend from it. It has been recalled once.
- Decided
- Mar 3, 2005
- Review
- 101 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K982481 (1998). 3 ancestors in all. 49 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 1 generation backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- This deviceK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005
- Descendant · cites it directly · 25 of its ownK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- Descendant · 2 generations on · 13 of its ownK111686 A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011
- Descendant · 2 generations on · 10 of its ownK092106 U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure…Taidoc Technology Corporation · 2010
- Descendant · cites it directly · 9 of its ownK113238 Full Automatic (Nibp) Blood Pressue MonitorHealth & Life Co., Ltd. · 2012
- Descendant · 2 generations on · 8 of its ownK142968 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K082734A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008 · cites it directly25descendants
- K111686A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011 · 2 generations on13descendants
- K092106U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor, Model TD-3132…Taidoc Technology Corporation · 2010 · 2 generations on10descendants
- K113238Full Automatic (Nibp) Blood Pressue MonitorHealth & Life Co., Ltd. · 2012 · cites it directly9descendants
- K142968Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | — |
| +1 | K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2008 | — |
| +2 | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure Monitors | A&D Company, Ltd. | 2011 | — |
| +2 | K092106 | U-Right TD-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor… | Taidoc Technology Corporation | 2010 | — |
| +1 | K113238 | Full Automatic (Nibp) Blood Pressue Monitor | Health & Life Co., Ltd. | 2012 | — |
| +2 | K142968 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (3)
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) K98248 1. Issued on Jan. 13, 1999 A&D UA-767BT, FDA 510(k) K040371. Issued on May 19, 2004… | 1998 |
| * | K040371 | A & D Medical UA-767BT Digital Blood Pressure MonitorSummary page 1…ivalent to the following device: A&D UA-767PC, FDA 510(k) K98248 1. Issued on Jan. 13, 1999 A&D UA-767BT, FDA 510(k) K040371. Issued on May 19, 2004 A&D UA-787, FDA 510(k) K012472. Issued on Feb. 15, 2002 t hI\t .. I)… | 2004 |
| * | K012472 | A & D Medical Lifesource UA-781, UA781PC, & UA-781T Digital Blood Pressure MonitorsSummary page 1…(k) K98248 1. Issued on Jan. 13, 1999 A&D UA-767BT, FDA 510(k) K040371. Issued on May 19, 2004 A&D UA-787, FDA 510(k) K012472. Issued on Feb. 15, 2002 t hI\t .. I) 5 I(,k) Stui ,,I I I3 Page I… | 2002 |
What descends from it? (49)
See all 4912 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | 2008 | 25 |
| K113238 | Full Automatic (Nibp) Blood Pressue Monitor | 2012 | 9 |
| K141160 | A&D Medical UA-651 Digital Blood Pressure Monitor | 2014 | 5 |
| K063484 | Patient Data Handler & Devices (PDH&D) | 2006 | 4 |
| K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | 2017 | 2 |
| K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | 2016 | 2 |
| K093981 | Yrnsortip Oximanometer | 2010 | 1 |
| K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | 2022 | 0 |
| K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | 2017 | 0 |
| K141201 | A&D Medical UA-767F and UA-767FAC Digital Blood Pressure Monitor | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2016 | Class II | Z-0063-2017 | Labeling Change Control | A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082734 (A&D Engineering, Inc., 2008) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K982481.
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-767PBT 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-767PBT memory. UA-767PBT 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. UA-767PBT 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/K043217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043217: A&D Medical UA-767PBT 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/K043217
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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