510(k) · Cleared
ClearedWrist Blood Pressure Monitor (BPM-W1VL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Imdk Medical Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 13, 2026 as substantially equivalent to K231310 (Shenzhen Jumper Medical Equipment Co., Ltd., 2023) after a 141-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Feb 13, 2026
- Review
- 141 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042505 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 3 generations backK131742 HEM-6131Omron Healthcare, Inc. · 2013
- 2 generations backK182127 Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc. · 2018
- 1 generation backK231310 Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd. · 2023
- This deviceK253133 Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −3 | K131742 | HEM-6131 | Omron Healthcare, Inc. | 2013 | — |
| −2 | K182127 | Wrist Blood Pressure Monitor Model BP6100 | Omron Healthcare, Inc. | 2018 | — |
| −1 | K231310 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | 2023 | — |
| 0 (this device) | K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K231310 | Electronic Blood Pressure MonitorSummary page 6…21 CFR 870.1130 4. Predicate Device Information 510(k) submitter/holder: Shenzhen Jumper Medical Equipment Co., Ltd 510(K) Number: K231310 Trade name: Electronic Blood Pressure Monitor Model: HWA10 Review Panel:… | 2023 |
| † | K221372 | YUWELL Electronic Blood Pressure Monitor | 2022 |
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 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K231310.
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. 2026, 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 Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of person older than twelve (12) years via non-invasive oscillometric technique in medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm. Contraindications: 1). Patients with severe heart (including significantly irregular heart rhythm, Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial…
Read the full statement (158 words)
The Wrist Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well
as the pulse rate of person older than twelve (12) years via non-invasive oscillometric technique in medical
facilities or at home. The intended wrist circumference is 13.5-21.5 cm.
Contraindications:
1). Patients with severe heart (including significantly irregular heart rhythm, Bigeminy, trigeminy, isolated
ventricular premature beat (VPB), atrial fibrillation), liver or kidney disease or blood circulation disorders.
2). Newborns, infants, children, people with mental disorders and people who cannot explain their thoughts;
3). The one who with upper limb trauma don't use this device;
4). The one who with artificial heart and skin ulcers is prohibited to use this device.
5). Patients are Pregnant;
6). Patients has been diagnosed with preeclampsia.
7). Patients with diabetes.
8). Patients who are undergoing vasoactive treatment.
9). Patients with (such as atrial fibrillation).
10). Patients with peripheral artery disease or other conditions that affect arterial compliance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253133: Wrist Blood Pressure Monitor (BPM-W1VL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253133
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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