510(k) · Cleared
ClearedArm-type Electronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Bsx Technology Electronics Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 3, 2019 as substantially equivalent to K170151 (Shenzhen Pango Electronic Co., Ltd., 2017) after a 243-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it.
- Decided
- Jul 3, 2019
- Review
- 243 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001670 (2000). 3 later devices descend from it, 3 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 deviceK183058 Arm-type Electronic Blood Pressure MonitorShenzhen Bsx Technology Electronics Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK211532 Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33Yibin Junxin Electronics Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210435 Automatic Arm Electronic Blood Pressure MonitorShenzhen Lepu Intelligent Medical Equipment Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK193387 Arm Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K211532Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33Yibin Junxin Electronics Technology Co., Ltd. · 2022 · cites it directly0descendants
- K210435Automatic Arm Electronic Blood Pressure MonitorShenzhen Lepu Intelligent Medical Equipment Co., Ltd. · 2021 · cites it directly0descendants
- K193387Arm Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd. · 2021 · cites it directly0descendants
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) | K183058 | Arm-type Electronic Blood Pressure Monitor | Shenzhen Bsx Technology Electronics Co., Ltd. | 2019 | — |
| +1 | K211532 | Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 | Yibin Junxin Electronics Technology Co., Ltd. | 2022 | — |
| +1 | K210435 | Automatic Arm Electronic Blood Pressure Monitor | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021 | — |
| +1 | K193387 | Arm Electronic Sphygmomanometer | Shenzhen Changkun Technology Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 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…Regulatory Class: Class II 3. Predicate Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood Pressure Device(s) Monitor / K170151 The Arm-type Electronic Blood Pressure Monitor is a battery powered automatic 4. Device n… | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K211532 (Yibin Junxin Electronics Technology Co., Ltd., 2022) has gone furthest, with 0 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 blood pressure monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183058: Arm-type 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/K183058
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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