510(k) · Cleared
ClearedAutomoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jawon Medical Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 9, 2009 as substantially equivalent to K062462 (Jawon Medical Co., Ltd., 2006) after a 63-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Oct 9, 2009
- Review
- 63 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895429 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK895429 A&D Automatic Digital Blood Pressure Meter 2650A&D Engineering, Inc. · 1989
- 1 generation backK062462 Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LJawon Medical Co., Ltd. · 2006
- This deviceK092432 Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)Jawon Medical Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK140762 Automatic Blood Pressure MonitorJawon Medical Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K140762Automatic Blood Pressure MonitorJawon Medical Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L) | Jawon Medical Co., Ltd. | 2009 | — |
| +1 | K140762 | Automatic Blood Pressure Monitor | Jawon Medical Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K062462 | Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LSummary page 1…and FT-700 (RIL) Predi~cate Device: Automatic Blood Pressure Monitor, Models FT-500 (RIL) (K062462, Sep. 29, 2006) Device Description: pressure monitors to non-in… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140762 | Automatic Blood Pressure Monitor | 2015 | 0 |
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 20 years and passes through 2 companies; a new generation was cleared every 16.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K140762 (Jawon Medical Co., Ltd., 2015) has gone furthest, with 0 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. 2009, 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?
Noninvasive measurement of systolic and diastolic blood pressure and determination of
heart rate in adult patients with age 16 or older and arm circumference range between'
9" to 14" (23cm to 36cm).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092432: Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092432
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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