510(k) · Cleared
ClearedAutomatic Blood Pressure Monitor
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 Jul 2, 2015 as substantially equivalent to K092432 (Jawon Medical Co., Ltd., 2009) after a 462-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Jul 2, 2015
- Review
- 462 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895429 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK895429 A&D Automatic Digital Blood Pressure Meter 2650A&D Engineering, Inc. · 1989
- 2 generations backK062462 Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LJawon Medical Co., Ltd. · 2006
- 1 generation backK092432 Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)Jawon Medical Co., Ltd. · 2009
- This deviceK140762 Automatic Blood Pressure MonitorJawon Medical Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895429 | A&D Automatic Digital Blood Pressure Meter 2650 | A&D Engineering, Inc. | 1989 | — |
| −2 | 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 | — |
| 0 (this device) | K140762 | Automatic Blood Pressure Monitor | Jawon Medical Co., Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)Summary page 4…Noninvasive Blood Pressure Measurement System, 74 DXN Predicate Device: Automatic Blood Pressure Monitor Jawon Model EASY X 900(R/L)_(K092432) Device descriptions: The EX PLUS 1300 is a blood pressure monitor to non-invasively measure blood pressures and heart rate at t… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
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. 2015, 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?
The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper…
Read the full statement (207 words)
The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is
for use by medical professional or home user. The EX PLUS 1300 is a device intended to
measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and
inter-arm pressure difference of an adult individual by using a non-invasive oscillometric
technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual)
upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.
Contraindications for use
As with any non-invasive measurement device, there are clinical conditions which can
influence the accuracy of the results. Also, the subject’s position, physiological condition and
other environmental factors can affect the measurement/calculation.
The EX PLUS 1300 Non-Invasive Blood Pressure Monitor should not be used with patients
who have the following conditions:
1. Patients with a known arrhythmia.
2. Patients with insufficient peripheral circulation, acute cases of low blood pressure or low
temperature.
3. Patients who use a pacemaker.
4. Patients experiencing a seizure.
5. Children younger than 18 years old.
6. Patients who should not have blood pressure measurements taken from their arms.
7. Patients with an artificial heart.
8. Patients whose artery cannot be found by palpation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140762: Automatic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140762
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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