510(k) · Cleared
ClearedOmron HEM-6400T-Z 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 Feb 21, 2017 as substantially equivalent to K142917 (Omron Healthcare, Inc., 2014) after a 113-day review. Its family tree reaches back 3 generations to 2005. 2 later devices descend from it.
- Decided
- Feb 21, 2017
- Review
- 113 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042505 (2005). 4 ancestors in all, the oldest K003732 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 2 generations backK123498 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2013
- 1 generation backK142917 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014
- This deviceK163045 Omron HEM-6400T-Z Wrist Blood Pressure MonitorOmron Healthcare, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK182481 HEM-6410T-ZM Wrist Blood Pressure MonitorOmron Healthcare, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK242568 Wrist Blood Pressure Monitor (OHMS11, OHMS12)Shenzhen Zhongkemingwang Telecommunications Software Corp. · 2025
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 |
|---|---|---|---|---|---|
| −3 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −2 | K123498 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2013 | — |
| −1 | K142917 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2014 | — |
| 0 (this device) | K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2017 | — |
| +1 | K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2018 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K142917 | BP652N (Hem-6300-Z)Summary page 5…8 510(k) SUMMARY (CONT.) PREDICATE DEVICE(S) The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is substantially equivalent to the Omron BP652N (HEM-6300-Z) with APS (K142917). DEVICE DESCRIPTION The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is a battery- powered automatic non-invasive blood press… | 2014 |
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 |
|---|---|---|---|
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | 2018 | 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 12 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K182481 (Omron Healthcare, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K142917.
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 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 inches to 8 inches (15.0 cm to 20.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163045: Omron HEM-6400T-Z 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/K163045
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