510(k) · Cleared
ClearedA&D Automatic Digital Blood Pressure Meter 2650
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 Nov 28, 1989 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 28, 1989
- Review
- 84 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK895429 A&D Automatic Digital Blood Pressure Meter 2650A&D Engineering, Inc. · 1989
- Descendant · cites it directly · 2 of its ownK062462 Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LJawon Medical Co., Ltd. · 2006
- Descendant · 2 generations on · 1 of its ownK092432 Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)Jawon Medical Co., Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK140762 Automatic Blood Pressure MonitorJawon Medical Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK983855 Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S &…Jawon Medical Co., Ltd. · 1998
Most influential descendants
Showing 4 of 4 · See all- K062462Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LJawon Medical Co., Ltd. · 2006 · cites it directly2descendants
- K092432Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)Jawon Medical Co., Ltd. · 2009 · 2 generations on1descendant
- K140762Automatic Blood Pressure MonitorJawon Medical Co., Ltd. · 2015 · 3 generations on0descendants
- K983855Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S & HD-2000FJawon Medical Co., Ltd. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895429 | A&D Automatic Digital Blood Pressure Meter 2650 | A&D Engineering, Inc. | 1989 | — |
| +1 | K062462 | Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/L | Jawon Medical Co., Ltd. | 2006 | — |
| +2 | K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L) | Jawon Medical Co., Ltd. | 2009 | — |
| +3 | K140762 | Automatic Blood Pressure Monitor | Jawon Medical Co., Ltd. | 2015 | — |
| +1 | K983855 | Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S & HD-2000F | Jawon Medical Co., Ltd. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K062462 (Jawon Medical Co., Ltd., 2006) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K895429 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895429: A&D Automatic Digital Blood Pressure Meter 2650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895429
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026