510(k) · Cleared
ClearedEvolv Model BP7000 Upper Arm 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 22, 2016 as substantially equivalent to K133383 (Omron Healthcare, Inc., 2014) after a 117-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Nov 22, 2016
- Review
- 117 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052153 (2005). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 2 generations backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- 1 generation backK133383 HEM-7320Omron Healthcare, Inc. · 2014
- This deviceK162092 Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK253059 Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252779 YUWELL® Electronic Blood Pressure Monitor (YE630CR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK241431 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L…Joytech Healthcare Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd. · 2026 · cites it directly0descendants
- K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2026 · cites it directly0descendants
- K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0…Joytech Healthcare Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −2 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| −1 | K133383 | HEM-7320 | Omron Healthcare, Inc. | 2014 | — |
| 0 (this device) | K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | Omron Healthcare, Inc. | 2016 | — |
| +1 | K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | 2026 | — |
| +1 | K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026 | — |
| +1 | K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B… | Joytech Healthcare Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K133383 | HEM-7320Summary page 5…DICATE DEVICE(S) The Evolv Model BP7000 Upper Arm Blood Pressure Monitor is substantially equivalent to the Omron HEM-7320 Noninvasive blood pressure measurement system (K133383). DEVICE DESCRIPTION The Evolv Model BP7000 Upper Arm Blood Pressure Monitor (“BP7000”) is a battery powered automatic non-inva… | 2014 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253059 (Tournicare Pty, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K133383.
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. 2016, 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 arm circumference ranging from 9 inches to 17 inches (22cm to 42cm). 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/K162092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162092: Evolv Model BP7000 Upper Arm 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/K162092
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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