510(k) · Cleared
ClearedHEM-6410T-ZM Wrist Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 9, 2018 as substantially equivalent to K163045 (Omron Healthcare, Inc., 2017) after a 60-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it.
- Decided
- Nov 9, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042505 (2005). 5 ancestors in all, the oldest K003732 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 3 generations backK123498 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2013
- 2 generations backK142917 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014
- 1 generation backK163045 Omron HEM-6400T-Z Wrist Blood Pressure MonitorOmron Healthcare, Inc. · 2017
- This deviceK182481 HEM-6410T-ZM Wrist Blood Pressure MonitorOmron Healthcare, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK242568 Wrist Blood Pressure Monitor (OHMS11, OHMS12)Shenzhen Zhongkemingwang Telecommunications Software Corp. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242568Wrist Blood Pressure Monitor (OHMS11, OHMS12)Shenzhen Zhongkemingwang Telecommunications Software Corp. · 2025 · cites it directly0descendants
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 | K123498 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2013 | — |
| −2 | K142917 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2014 | — |
| −1 | K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2017 | — |
| 0 (this device) | K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2018 | — |
| +1 | K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K163045 | Omron HEM-6400T-Z Wrist Blood Pressure MonitorSummary page 5…PREDICATE DEVICE(S) [807.92(a)(3)] The Omron HEM-6410T-ZM Wrist Blood Pressure Monitor is substantially equivalent to the Omron HEM-6400T-Z (K163045). DEVICE DESCRIPTION [807.92(a)(4)] The Omron HEM-6410T-ZM Wrist Blood Pressure Monitor (“HEM-6410T-ZM”) is… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | 2025 | 0 |
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 13 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K242568 (Shenzhen Zhongkemingwang Telecommunications Software Corp., 2025) has gone furthest, with 0 descendants of its own.
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 device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 6.3 inches to 7.5 inches (16.0cm to 19.0cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182481: HEM-6410T-ZM Wrist 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/K182481
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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