510(k) · Cleared
ClearedABPM 7100, Hypertension Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.E.M. GmbH · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 19, 2016 as substantially equivalent to K140928 (I.E.M. GmbH, 2014) after a 218-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 19, 2016
- Review
- 218 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K950779 (1995). 14 ancestors in all, the oldest K855127 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 6 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 5 generations backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- 4 generations backK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
- 3 generations backK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- 2 generations backK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
- 1 generation backK140928 ABPM7100I.E.M. GmbH · 2014
- This deviceK153557 ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −6 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −5 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| −4 | K993875 | BMT Anscore Health Management System | Boston Medical Technologies, Inc. | 2000 | — |
| −3 | K070795 | Sphygmocor Cardiovascular Management System | Atcor Medical Pty, Ltd. | 2007 | — |
| −2 | K110603 | Hypertension Management Software Claient Server (HMS-CS) | I.E.M. GmbH | 2011 | — |
| −1 | K140928 | ABPM7100 | I.E.M. GmbH | 2014 | — |
| 0 (this device) | K153557 | ABPM 7100, Hypertension Management Software | I.E.M. GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K140928 | ABPM7100Summary page 4…Product Code: DXN Device Class: Class II Classification Panel: Cardiovascular Legally Marketed Predicate Device K140928, ABPM 7100 PWA with Hypertension Management Software Client Server 4.7 Page Section 05-1… | 2014 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 ancestors has a recall.
- 1 other device also cites its predicate K140928.
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. 2016, 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 ABPM 7100 is an automated, microprocessor controlled ambulatory blood pressure monitor (ABPM) which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual patient (in the patient’s environment) for a session which may last 24 hours. Ambulatory monitoring is not supported for the 14-20 cm cuff size. It is used with a standard upper-arm cuff for blood pressure measurement. The ABPM 7100 in combination with the…
Read the full statement (130 words)
The ABPM 7100 is an automated, microprocessor controlled ambulatory blood pressure monitor (ABPM) which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual patient (in the patient’s environment) for a session which may last 24 hours. Ambulatory monitoring is not supported for the 14-20 cm cuff size.
It is used with a standard upper-arm cuff for blood pressure measurement.
The ABPM 7100 in combination with the Hypertension Management Software (IIMS) provides a derived ascending aortic blood pressure wave form and a range of central arterial indices. It is used in those adult patients, where information related to the ascending aortic blood pressure is desired, but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
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/K153557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153557: ABPM 7100, Hypertension Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153557
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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