510(k) · Cleared
ClearedWrist Type Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuzhou Yongkang Electronic Science Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 9, 2018 as substantially equivalent to K131569 (Shenzhen Pango Electronic Co., Ltd., 2013) after a 535-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 9, 2018
- Review
- 535 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001671 (2000). No later device cites it as a predicate yet.
- 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 deviceK162616 Wrist Type Blood Pressure MonitorXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2018
View 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) | K162616 | Wrist Type Blood Pressure Monitor | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2018 | — |
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 6…2 510(k) Summary 6. Identification of Predicate Device Predicate # 510(k) Number: K131569 Product Name: PG 800A Series Electronic Blood Pressure Monitor Manufacturer: Shenzhen Pango Electronic Co., Ltd. 7.… | 2013 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- 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. 2018, 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 Wrist Type 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 cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162616: Wrist Type 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/K162616
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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