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 Pango Electronic Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 31, 2017 as substantially equivalent to K131569 (Shenzhen Pango Electronic Co., Ltd., 2013) after a 391-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Jul 31, 2017
- Review
- 391 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001671 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK001671 Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model…Omron Healthcare, Inc. · 2000
- 4 generations backK030359 KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 3 generations backK070826 KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 2 generations backK102920 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2010
- 1 generation backK131569 PG-800A SeriesShenzhen Pango Electronic Co., Ltd. · 2013
- This deviceK161845 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK223291 Electronic Blood Pressure MonitorShenzhen Pango Medical Electronics Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK232815 Wrist Blood Pressure MonitorZhuhai Yueja Medical Device Technology Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001671 | Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630 | Omron Healthcare, Inc. | 2000 | — |
| −4 | K030359 | KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −3 | K070826 | KD-795 Wrist Measurement Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −2 | K102920 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2010 | — |
| −1 | K131569 | PG-800A Series | Shenzhen Pango Electronic Co., Ltd. | 2013 | — |
| 0 (this device) | K161845 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2017 | — |
| +1 | K223291 | Electronic Blood Pressure Monitor | Shenzhen Pango Medical Electronics Co., Ltd. | 2023 | — |
| +2 | K232815 | Wrist Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K131569 | PG-800A SeriesSummary page 5…e product appearance. The proposed device is intended to be used in medical facilities or at home. 5. Identification of Predicate Device 510(k) Number: K131569 Product Name: PG-800A Series Electronic Blood Pressure Monitor Models: PG-800A5, PG-800A5D Manufacturer: Shenzhen… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223291 | Electronic Blood Pressure Monitor | 2023 | 1 |
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 17 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K223291 (Shenzhen Pango Medical Electronics Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K131569.
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. 2017, 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 in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.
The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adult) and adults (at least 22 years of age).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161845: Electronic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161845
Report an extraction error
Are you the manufacturer?
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