510(k) · Cleared
ClearedA&D Medical TM-2657 Family of Digital 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 13, 2016 as substantially equivalent to K043217 (A&D Engineering, Inc., 2005) and 1 other predicate after a 273-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Apr 13, 2016
- Review
- 273 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K982481 (1998). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 2 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 1 generation backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- This deviceK151953 A&D Medical TM-2657 Family of Digital Blood Pressure MonitorsA&D Company, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK251102 Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606…Cemho Medical Technology (Guangdong) Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK200287 BP-BT KioskLd Technology, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −2 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −1 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| 0 (this device) | K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | A&D Company, Ltd. | 2016 | — |
| +1 | K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L… | Cemho Medical Technology (Guangdong) Co., Ltd. | 2025 | — |
| +1 | K200287 | BP-BT Kiosk | Ld Technology, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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…21 CFR 870.1130, Class II, DXN. 4. Predicate Devices A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 A&D Model TM-2655 Family (TM-2655, TM-2655P and TM-2655PV) of Digital Blood Pressure Monitors with… | 2005 |
| * | K010828 | Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VPSummary page 4…with 510(k) number K043217 A&D Model TM-2655 Family (TM-2655, TM-2655P and TM-2655PV) of Digital Blood Pressure Monitors with 510(k) number K010828 Both predicate devices are designed and manufactured by the same company and facilities as the modified dev… | 2001 |
What descends from it? (2)
2 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 18 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K251102 (Cemho Medical Technology (Guangdong) Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 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. 2016, 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-2657, TM-2657P, TM-2657PBT, and TM-2657PRS are designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 7.1 inches (18.0 cm) to 13.8 inches (35.0 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/K151953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151953: A&D Medical TM-2657 Family of Digital 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/K151953
Report an extraction error
Are you the manufacturer?
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