510(k) · Cleared
ClearedA&D Medical Blood Pressure Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A&D Company, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 21, 2019 as substantially equivalent to K061456 (A&D Engineering, Inc., 2006) and 1 other predicate after a 535-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Mar 21, 2019
- Review
- 535 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K982481 (1998). 10 ancestors in all, the oldest K871718 (1987). 1 later device descends from it, 1 citing it directly.
- 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 deviceK173191 A&D Medical Blood Pressure MonitorsA&D Company, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK212168 A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K212168A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd. · 2022 · cites it directly0descendants
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) | K173191 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | 2019 | — |
| +1 | K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | A&D Company, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K061456 | A & D Medical UM-101 Digital Blood Pressure MonitorSummary page 4…Product Code: DXQ & DNX 4. Information of the Predicate Devices A&D Medical UM-101 Digital Blood Pressure Monitor with 510(k) number K061456 A&D Medical UA-1000 Series Digital Blood Pressure Monitors with 510(k) number K111686 5. Indic… | 2006 |
| * | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsSummary page 4…101 Digital Blood Pressure Monitor with 510(k) number K061456 A&D Medical UA-1000 Series Digital Blood Pressure Monitors with 510(k) number K111686 5. Indications for Use UM-211 blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse r… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | 2022 | 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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K212168 (A&D Company, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061456.
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. 2019, 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?
UM-211 blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of adults who are twelve (12) years and older in the clinics and hospitals. The arm size is from 16 cm (6.3 inches) to 50 cm (19.7 inches). UM-211 can measure blood pressure in auscultatory (device class DXQ) and oscillometric (device class DXN) methods. It can detect irregular heartbeats and display a symbol on its display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173191: A&D Medical Blood Pressure Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173191
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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