510(k) · Cleared
ClearedDigital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP
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 Mar 29, 2001 after a 9-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Mar 29, 2001
- Review
- 9 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK010828 Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VPA&D Engineering, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK131064 BiospaceBiospace Corporation Limited · 2013
- Descendant · 2 generations on · 2 of its ownK200442 InBodyInbody Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK151953 A&D Medical TM-2657 Family of Digital Blood Pressure MonitorsA&D Company, Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK221764 InBody Blood pressure monitor, Model BPBIO480KVInbody Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251102 Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606…Cemho Medical Technology (Guangdong) Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131064BiospaceBiospace Corporation Limited · 2013 · cites it directly4descendants
- K200442InBodyInbody Co., Ltd. · 2020 · 2 generations on2descendants
- K151953A&D Medical TM-2657 Family of Digital Blood Pressure MonitorsA&D Company, Ltd. · 2016 · cites it directly2descendants
- K221764InBody Blood pressure monitor, Model BPBIO480KVInbody Co., Ltd. · 2022 · 3 generations on1descendant
- K251102Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602…Cemho Medical Technology (Guangdong) Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010828 | Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP | A&D Engineering, Inc. | 2001 | — |
| +1 | K131064 | Biospace | Biospace Corporation Limited | 2013 | — |
| +2 | K200442 | InBody | Inbody Co., Ltd. | 2020 | — |
| +1 | K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | A&D Company, Ltd. | 2016 | — |
| +3 | K221764 | InBody Blood pressure monitor, Model BPBIO480KV | Inbody Co., Ltd. | 2022 | — |
| +2 | K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L… | Cemho Medical Technology (Guangdong) Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
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?
- Of its descendants, K131064 (Biospace Corporation Limited, 2013) has gone furthest, with 4 descendants of its own.
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?
The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K010828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010828: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010828
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026