510(k) · Cleared
ClearedTerumo Digital Blood Pressure Monitor ES-H55A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 25, 2007 as substantially equivalent to K032499 (A&D Engineering, Inc., 2003) and 1 other predicate after a 39-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- May 25, 2007
- Review
- 39 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K871718 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK871718 Modified Model UA-711 Digital SphygmonometerA&D Engineering, Inc. · 1987
- 1 generation backK032499 A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsA&D Engineering, Inc. · 2003
- This deviceK071075 Terumo Digital Blood Pressure Monitor ES-H55ATerumo Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871718 | Modified Model UA-711 Digital Sphygmonometer | A&D Engineering, Inc. | 1987 | — |
| −1 | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2003 | — |
| 0 (this device) | K071075 | Terumo Digital Blood Pressure Monitor ES-H55A | Terumo Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsSummary page 1…10 Substantial Equivalence: The legally marketed devices to which substantial equivalence is demonstrated are A & D Lifesource, UA-704 Digital Blood Pressure Monitor (K032499) and the American Diagnostic Corporation e-sphyg digital Aneroid Blood Pressure Instrument (K962655). The subject device is s… | 2003 |
| * | K962655 | Aneroid and Mercurial SphygmomanometersSummary page 1…trated are A & D Lifesource, UA-704 Digital Blood Pressure Monitor (K032499) and the American Diagnostic Corporation e-sphyg digital Aneroid Blood Pressure Instrument (K962655). The subject device is substantially equivalent with the predicate devices in the intended use, design, principle of operati… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K032499.
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. 2007, 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 TERUMO digital blood pressure monitor ES-H55A is a non-invasive device to measure blood pressure at upper arm for pediatric(age 3 and above ) except for neonate and infant, and adult, using an appropriate sized cuff. It measures systolic and diastolic blood pressures and pulse rate using oscillometric method, also it serves as a manual sphygmomanometer using a stethoscope. It is intended for professional use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071075: Terumo Digital Blood Pressure Monitor ES-H55A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071075
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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