510(k) · Cleared
ClearedOmron Digital Blood Pressure Monitor Model HEM814F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Electronics, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 6, 1990 after a 228-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 6, 1990
- Review
- 228 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK894563 Omron Digital Blood Pressure Monitor Model HEM814FOmron Electronics, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK081924 Calhealth, Inc., Finger Blood Pressure Monitor, MdmouseCalhealth, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK261061 BP Go (BPP-855)Wellvii, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK954547 CH-502A & CH520B Digital Finger SphygmomanometerCitizen Watch Co., Ltd. · 1997
Most influential descendants
Showing 3 of 3 · See all- K081924Calhealth, Inc., Finger Blood Pressure Monitor, MdmouseCalhealth, Inc. · 2009 · cites it directly1descendant
- K261061BP Go (BPP-855)Wellvii, Inc. · 2026 · 2 generations on0descendants
- K954547CH-502A & CH520B Digital Finger SphygmomanometerCitizen Watch Co., Ltd. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894563 | Omron Digital Blood Pressure Monitor Model HEM814F | Omron Electronics, Inc. | 1990 | — |
| +1 | K081924 | Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse | Calhealth, Inc. | 2009 | — |
| +2 | K261061 | BP Go (BPP-855) | Wellvii, Inc. | 2026 | — |
| +1 | K954547 | CH-502A & CH520B Digital Finger Sphygmomanometer | Citizen Watch Co., Ltd. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K081924 (Calhealth, Inc., 2009) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K894563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894563: Omron Digital Blood Pressure Monitor Model HEM814F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894563
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026