510(k) · Cleared
ClearedElectronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Jumper Medical Equipment Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 3, 2019 as substantially equivalent to K170151 (Shenzhen Pango Electronic Co., Ltd., 2017) after a 173-day review. Its family tree reaches back 6 generations to 2000. 11 later devices descend from it.
- Decided
- Mar 3, 2019
- Review
- 173 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001670 (2000). 11 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 5 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 4 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 3 generations backK102988 Electronic Blood Presure MonitorShenzhen Pango Electronic Co., Ltd. · 2010
- 2 generations backK131558 PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3…Shenzhen Pango Electronic Co., Ltd. · 2013
- 1 generation backK170151 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2017
- This deviceK182495 Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd. · 2019
- Descendant · cites it directly · 10 of its ownK191180 Electronic Blood Pressure MonitorShenzhen AOJ Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 4 of its ownK222125 Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK222994 Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BShenzhen AOJ Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK213503 Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK261136 Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K191180Electronic Blood Pressure MonitorShenzhen AOJ Medical Technology Co., Ltd. · 2019 · cites it directly10descendants
- K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F…Shenzhen AOJ Medical Technology Co., Ltd. · 2022 · 2 generations on4descendants
- K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BShenzhen AOJ Medical Technology Co., Ltd. · 2023 · 2 generations on1descendant
- K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −5 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −4 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −3 | K102988 | Electronic Blood Presure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2010 | — |
| −2 | K131558 | PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4… | Shenzhen Pango Electronic Co., Ltd. | 2013 | — |
| −1 | K170151 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2017 | — |
| 0 (this device) | K182495 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | 2019 | — |
| +1 | K191180 | Electronic Blood Pressure Monitor | Shenzhen AOJ Medical Technology Co., Ltd. | 2019 | — |
| +2 | K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D… | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +2 | K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | Shenzhen AOJ Medical Technology Co., Ltd. | 2023 | — |
| +2 | K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +3 | K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K170151 | Electronic Blood Pressure MonitorSummary page 4…ew Application. Submission 4. Predicate Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood Pressure Device(s): Monitor / K170151 JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor is a battery 5. Device po… | 2017 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191180 | Electronic Blood Pressure Monitor | 2019 | 10 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K191180 (Shenzhen AOJ Medical Technology Co., Ltd., 2019) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K170151.
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. 2019, 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 Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182495: Electronic 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/K182495
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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