510(k) · Cleared
ClearedA & D Medical UM-101 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 Jun 21, 2006 as substantially equivalent to K032499 (A&D Engineering, Inc., 2003) after a 27-day review. Its family tree reaches back 2 generations to 1987. 4 later devices descend from it.
- Decided
- Jun 21, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871718 (1987). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK871718 Modified Model UA-711 Digital SphygmonometerA&D Engineering, Inc. · 1987
- 1 generation backK032499 A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsA&D Engineering, Inc. · 2003
- This deviceK061456 A & D Medical UM-101 Digital Blood Pressure MonitorA&D Engineering, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK173191 A&D Medical Blood Pressure MonitorsA&D Company, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK212168 A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK200560 InBodyInbody Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK092893 Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual…Tytan Medical Corp. · 2010
Most influential descendants
Showing 4 of 4 · See all- K173191A&D Medical Blood Pressure MonitorsA&D Company, Ltd. · 2019 · cites it directly1descendant
- K212168A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd. · 2022 · 2 generations on0descendants
- K200560InBodyInbody Co., Ltd. · 2021 · cites it directly0descendants
- K092893Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD…Tytan Medical Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871718 | Modified Model UA-711 Digital Sphygmonometer | A&D Engineering, Inc. | 1987 | — |
| −1 | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2003 | — |
| 0 (this device) | K061456 | A & D Medical UM-101 Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2006 | — |
| +1 | K173191 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | 2019 | — |
| +2 | K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | A&D Company, Ltd. | 2022 | — |
| +1 | K200560 | InBody | Inbody Co., Ltd. | 2021 | — |
| +1 | K092893 | Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD… | Tytan Medical Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsSummary page 1…pulse rate. S. PREDICATE DEVCIE A&D LifeSource model UA-704 digital blood pressure monitor with FDA 5 10O(k) K032499. 6. TECHNOLOGICAL CHARACTERISTICS UTM-101 uses an inflated cuff which is wrapped around the… | 2003 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 1 company; a new generation was cleared every 16.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K173191 (A&D Company, Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K032499.
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?
Measure blood pressure (systolic and diastolic) and pulse rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061456: A & D Medical UM-101 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/K061456
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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