510(k) · Cleared
ClearedAuto Digital Upper Arm Blood Pressure Monitor, Model KP-7770
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 Oct 9, 2009 as substantially equivalent to K083753 (K-Jump Health Co., Ltd., 2009) after a 28-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Oct 9, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083753 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK083753 Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model…K-Jump Health Co., Ltd. · 2009
- This deviceK092806 Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770K-Jump Health Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083753 | Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, Fully… | K-Jump Health Co., Ltd. | 2009 | — |
| 0 (this device) | K092806 | Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770 | K-Jump Health Co., Ltd. | 2009 | — |
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 |
|---|---|---|---|
| * | K083753 | Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, Fully Fuzzy…Summary page 1…nt, Blood Pressure, Non-Invasive Predicate Device K-jump Health Co., Ltd.'s Arm Blood Pressure Monitor Smartlogic Model K'P-7500 and Fuzzylogic Model IKP-7500D, K(083753. Intended Use/Indications for Use The device is intended to measure the systolic and diastolic blood pressure an… | 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?
- Its one ancestor has no 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. 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-7770 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff 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/K092806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092806: Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092806
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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