510(k) · Cleared
ClearedSmart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, Fully Fuzzy Auto Digital Upper Arm Blood Pressu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K-Jump Health Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 19, 2009 after a 184-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 19, 2009
- Review
- 184 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK083753 Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model…K-Jump Health Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK092806 Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770K-Jump Health Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K092806Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770K-Jump Health Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083753 | Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, Fully… | K-Jump Health Co., Ltd. | 2009 | — |
| +1 | K092806 | Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770 | K-Jump Health Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | — | K-jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model KP-6210 Named without a submission number | |
| * | — | K-jump Health Co., Ltd.'s Arm BPM Blood Pressure Monitor Model KP-6821 and KP-6822 Named without a submission number | |
| * | — | MicroLife's Upper Arm Blood Pressure Monitor Model BP-3BTO-AP Named without a submission number |
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 |
|---|---|---|---|
| K092806 | Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770 | 2009 | 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?
- Of its descendants, K092806 (K-Jump Health Co., Ltd., 2009) 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?
The KP-7500 and KP-7500D are intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. It is indicated for use in adults.
The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083753: Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, Fully Fuzzy Auto Digital Upper Arm Blood Pressu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083753
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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