510(k) · Cleared
ClearedHem-7200-Z (BP742)
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 Aug 29, 2012 as substantially equivalent to K052153 (Omron Healthcare, Inc., 2005) after a 58-day review. Its family tree reaches back 1 generation to 2005. 34 later devices descend from it.
- Decided
- Aug 29, 2012
- Review
- 58 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052153 (2005). 34 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- This deviceK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- Descendant · cites it directly · 17 of its ownK133383 HEM-7320Omron Healthcare, Inc. · 2014
- Descendant · 2 generations on · 11 of its ownK170605 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2018
- Descendant · cites it directly · 9 of its ownK133379 HEM-7311Omron Healthcare, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK200939 Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK130325 Arm Automatic Blood Pressure MonitorShenzhen Pump Medical System Co., Ltd. · 2013
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K133383HEM-7320Omron Healthcare, Inc. · 2014 · cites it directly17descendants
- K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2018 · 2 generations on11descendants
- K133379HEM-7311Omron Healthcare, Inc. · 2014 · cites it directly9descendants
- K200939Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020 · 3 generations on6descendants
- K130325Arm Automatic Blood Pressure MonitorShenzhen Pump Medical System Co., Ltd. · 2013 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| 0 (this device) | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| +1 | K133383 | HEM-7320 | Omron Healthcare, Inc. | 2014 | — |
| +2 | K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood… | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2018 | — |
| +1 | K133379 | HEM-7311 | Omron Healthcare, Inc. | 2014 | — |
| +3 | K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020 | — |
| +1 | K130325 | Arm Automatic Blood Pressure Monitor | Shenzhen Pump Medical System Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CRELSummary page 1…0.1130 Class 11 Device: Model HEM-7200-Z (BP742) Predicate Device: Omron - HIEM-741ICRELN - K052 153 Device Description: The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be… | 2005 |
What descends from it? (34)
See all 345 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?
- Its one ancestor has no recall.
- Of its descendants, K133383 (Omron Healthcare, Inc., 2014) has gone furthest, with 17 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. 2012, 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/K121932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121932: Hem-7200-Z (BP742).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121932
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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