510(k) · Cleared
ClearedHEM-7320
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 Mar 4, 2014 as substantially equivalent to K061822 (Omron Healthcare, Inc., 2006) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 2005. 17 later devices descend from it.
- Decided
- Mar 4, 2014
- Review
- 120 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K052153 (2005). 3 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 1 generation backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- This deviceK133383 HEM-7320Omron Healthcare, Inc. · 2014
- Descendant · cites it directly · 11 of its ownK170605 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2018
- Descendant · 2 generations on · 6 of its ownK200939 Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK162092 Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK223170 Electronic Blood Pressure Monitor, model: HTD6602USHetaida Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK193456 Arm Blood Pressure MonitorNingbo Ranor Medical Science & Technology Co., Ltd. · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2018 · cites it directly11descendants
- K200939Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020 · 2 generations on6descendants
- K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. · 2016 · cites it directly3descendants
- K223170Electronic Blood Pressure Monitor, model: HTD6602USHetaida Technology Co., Ltd. · 2023 · 3 generations on1descendant
- K193456Arm Blood Pressure MonitorNingbo Ranor Medical Science & Technology Co., Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −1 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| 0 (this device) | K133383 | HEM-7320 | Omron Healthcare, Inc. | 2014 | — |
| +1 | K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood… | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2018 | — |
| +2 | K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020 | — |
| +1 | K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | Omron Healthcare, Inc. | 2016 | — |
| +3 | K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. | 2023 | — |
| +2 | K193456 | Arm Blood Pressure Monitor | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3Summary page 1…870.1130 Class 11 Device: Model HEM-7320 Predicate Devices: Omron -HEM -780N3 (HEM-7080-Z)- K061822 Omtron - BP742 (HEM-7200-Z) - K 121932 Device Description: The device is an automatic non-inva… | 2006 |
| * | K121932 | Hem-7200-Z (BP742)Summary page 1…Model HEM-7320 Predicate Devices: Omron -HEM -780N3 (HEM-7080-Z)- K061822 Omtron - BP742 (HEM-7200-Z) - K 121932 Device Description: The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be… | 2012 |
What descends from it? (17)
See all 173 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 9 years and passes through 1 company; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K170605 (Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., 2018) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K061822.
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. 2014, 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.
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/K133383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133383: HEM-7320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133383
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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