510(k) · Cleared
ClearedAutomatic Arm Electronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 12, 2021 as substantially equivalent to K183058 (Shenzhen Bsx Technology Electronics Co., Ltd., 2019) after an 89-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- May 12, 2021
- Review
- 89 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001670 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 6 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 5 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 4 generations backK102988 Electronic Blood Presure MonitorShenzhen Pango Electronic Co., Ltd. · 2010
- 3 generations backK131558 PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3…Shenzhen Pango Electronic Co., Ltd. · 2013
- 2 generations backK170151 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2017
- 1 generation backK183058 Arm-type Electronic Blood Pressure MonitorShenzhen Bsx Technology Electronics Co., Ltd. · 2019
- This deviceK210435 Automatic Arm Electronic Blood Pressure MonitorShenzhen Lepu Intelligent Medical Equipment Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −6 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −5 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −4 | K102988 | Electronic Blood Presure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2010 | — |
| −3 | K131558 | PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4… | Shenzhen Pango Electronic Co., Ltd. | 2013 | — |
| −2 | K170151 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2017 | — |
| −1 | K183058 | Arm-type Electronic Blood Pressure Monitor | Shenzhen Bsx Technology Electronics Co., Ltd. | 2019 | — |
| 0 (this device) | K210435 | Automatic Arm Electronic Blood Pressure Monitor | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | K183058 | Arm-type Electronic Blood Pressure MonitorSummary page 4…ent System Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular Classification: II 5.5. Predicate Device 510(k) Number: K183058 Device Name: Arm-type Electronic Blood Pressure Monitor Manufacturer: Shenzhen BSX Technology Electronics Co., Ltd. Pa… | 2019 |
| † | K192609 | Globalcare Blood Pressure Monitor | 2020 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K183058.
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. 2021, 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 device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210435: Automatic Arm 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/K210435
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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