510(k) · Cleared
ClearedNon-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/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 Sep 29, 2006 as substantially equivalent to K895429 (A&D Engineering, Inc., 1989) after a 36-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895429 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK895429 A&D Automatic Digital Blood Pressure Meter 2650A&D Engineering, Inc. · 1989
- This deviceK062462 Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LJawon Medical Co., Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK092432 Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)Jawon Medical Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK140762 Automatic Blood Pressure MonitorJawon Medical Co., Ltd. · 2015
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 |
|---|---|---|---|---|---|
| −1 | K895429 | A&D Automatic Digital Blood Pressure Meter 2650 | A&D Engineering, Inc. | 1989 | — |
| 0 (this device) | K062462 | Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/L | Jawon Medical Co., Ltd. | 2006 | — |
| +1 | K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L) | Jawon Medical Co., Ltd. | 2009 | — |
| +2 | K140762 | Automatic Blood Pressure Monitor | Jawon Medical Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K895429 | A&D Automatic Digital Blood Pressure Meter 2650Summary page 1…re Monitor Classification Name: Noninvasive Blood Pressure Measurement System, 74 DXN 3. PREDICATE DEVICE. A&D Model TM-2650 Automatic Blood Pressure Meter K895429, SE decision 11/28/89 4. DEVICE DESCRIPTION. General: Models FT-500 and FT-700 of the Jawon system are com… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L) | 2009 | 1 |
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?
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?
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/K062462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062462: Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062462
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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