510(k) · Cleared
ClearedA&D Medical UA-767F and UA-767FAC 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 8, 2014 as substantially equivalent to K043217 (A&D Engineering, Inc., 2005) and 1 other predicate after a 152-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Oct 8, 2014
- Review
- 152 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. No later device cites it as a predicate yet.
- 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 deviceK141201 A&D Medical UA-767F and UA-767FAC Digital Blood Pressure MonitorA & D Co., Ltd. · 2014
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) | K141201 | A&D Medical UA-767F and UA-767FAC Digital Blood Pressure Monitor | A & D Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 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 4…stem 21 CFR 870-1130, Class II, 74DXN. 4. Predicate Devices A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 A&D Model UA-1000 Family Digital Blood Pressure Monitors with 510(k) number K111686 Predicate devices are designed… | 2005 |
| * | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsSummary page 4…s A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 A&D Model UA-1000 Family Digital Blood Pressure Monitors with 510(k) number K111686 Predicate devices are designed and manufactured by the same company and facilities as the modified devices UA-767F… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 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. 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?
The UA-767F and UA-767FAC are designed to be used by users who are older than twelve (12) years at home or clinics to monitor their blood pressure (systolic and diastolic) and pulse rate. The arm circumference range shall be between 8.7 inches (22.0 cm) and 17.7 inches (45.0 cm).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141201: A&D Medical UA-767F and UA-767FAC 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/K141201
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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