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 Apr 24, 2019 as substantially equivalent to K992808 (A&D Medical Div., 1999) after a 572-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 24, 2019
- Review
- 572 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992808 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992808 A&D Medical TM-2430 and TM-2431 Ambulatory Blood PressureA&D Medical Div. · 1999
- This deviceK173065 A&D Medical Blood Pressure MonitorsA&D Company, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992808 | A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure | A&D Medical Div. | 1999 | — |
| 0 (this device) | K173065 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | 2019 | — |
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 |
|---|---|---|---|
| * | K992808 | A&D Medical TM-2430 and TM-2431 Ambulatory Blood PressureSummary page 4…ormation for he 510(k) Cleared Devices (Predicate Devices) A&D Medical TM-2430 & TM-2431 Digital Blood Pressure Monitors with 510(k) number K992808 5. Indications for Use TM-2440 and TM-2441 blood pressure monitors are designed to measure systolic and diastolic… | 1999 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K992808.
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?
TM-2440 and TM-2441 blood pressure monitors are designed to monitor systolic and diastolic
pressure, and pulse rate of adults who are twelve (12) years and older by using the oscillometric
method.
TM-2441 has four environmental functions to measure activity monitoring (3-axis accelerometer) ,
ambient temperature monitoring, barometric pressure monitoring, and waveform capability. These
functions are not observed by patients form the device display and can only be used by the medical
professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173065: 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/K173065
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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