510(k) · Cleared
ClearedHEM-7311
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 Jan 16, 2014 as substantially equivalent to K121932 (Omron Healthcare, Inc., 2012) after a 73-day review. Its family tree reaches back 2 generations to 2005. 9 later devices descend from it.
- Decided
- Jan 16, 2014
- Review
- 73 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052153 (2005). 9 later devices descend from it, 4 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 deviceK133379 HEM-7311Omron Healthcare, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK182579 Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK163235 HEM-9210TOmron Healthcare, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK240832 Blood Pressure Monitor (BBZ32-AA01)Guangdong Transtek Medical Electronics Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK201467 Blood Pressure Monitor-Model 2005, 2006-2, 2006-2BBioland Technology, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK261929 Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2019 · cites it directly2descendants
- K163235HEM-9210TOmron Healthcare, Inc. · 2017 · cites it directly2descendants
- K240832Blood Pressure Monitor (BBZ32-AA01)Guangdong Transtek Medical Electronics Co., Ltd. · 2024 · cites it directly1descendant
- K201467Blood Pressure Monitor-Model 2005, 2006-2, 2006-2BBioland Technology, Ltd. · 2020 · 2 generations on1descendant
- K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026 · cites it directly0descendants
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) | K133379 | HEM-7311 | Omron Healthcare, Inc. | 2014 | — |
| +1 | K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | 2019 | — |
| +1 | K163235 | HEM-9210T | Omron Healthcare, Inc. | 2017 | — |
| +1 | K240832 | Blood Pressure Monitor (BBZ32-AA01) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024 | — |
| +2 | K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | Bioland Technology, Ltd. | 2020 | — |
| +1 | K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K121932 | Hem-7200-Z (BP742)Summary page 1…R 870.1130 Class 11 Device: Model l-EM-73 II Predicate Devices: Omron -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? (9)
4 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 2 ancestors has a recall.
- Of its descendants, K182579 (Omron Healthcare, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K121932.
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 as stated in the FDA summary.
https://510kreport.com/device/K133379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133379: HEM-7311.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133379
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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