510(k) · Cleared
ClearedABPM7100
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 Sep 15, 2014 as substantially equivalent to K110603 (I.E.M. GmbH, 2011) after a 157-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it.
- Decided
- Sep 15, 2014
- Review
- 157 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950779 (1995). 13 ancestors in all, the oldest K855127 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 5 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 4 generations backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- 3 generations backK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
- 2 generations backK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- 1 generation backK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
- This deviceK140928 ABPM7100I.E.M. GmbH · 2014
- Descendant · cites it directly · 3 of its ownK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK251581 Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK153557 ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH · 2016
Most influential descendants
Showing 5 of 5 · See all- K151520Oscar 2Suntech Medical, Inc. · 2016 · cites it directly3descendants
- K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc. · 2021 · 2 generations on1descendant
- K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026 · 2 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 3 generations on0descendants
- K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −5 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −4 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| −3 | K993875 | BMT Anscore Health Management System | Boston Medical Technologies, Inc. | 2000 | — |
| −2 | K070795 | Sphygmocor Cardiovascular Management System | Atcor Medical Pty, Ltd. | 2007 | — |
| −1 | K110603 | Hypertension Management Software Claient Server (HMS-CS) | I.E.M. GmbH | 2011 | — |
| 0 (this device) | K140928 | ABPM7100 | I.E.M. GmbH | 2014 | — |
| +1 | K151520 | Oscar 2 | Suntech Medical, Inc. | 2016 | 2 |
| +2 | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | 2021 | — |
| +2 | K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026 | — |
| +3 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K110603 | Hypertension Management Software Claient Server (HMS-CS)Summary page 5…510(k) Summary 4. Legally Marketed Predicate Device K110603 Mobil-O-Graph 24h PWA and HMS CS Version 4.3 by I.E.M. GmbH 5. Device Description: The ABPM 7100 consist of… | 2011 |
What descends from it? (5)
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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K151520 (Suntech Medical, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K110603.
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 ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 hours. The ABPM 7100 in combination with Hypertension Management Software Client Server (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central…
Read the full statement (133 words)
The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors,
accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's
environment) for a session which may last 24 hours.
The ABPM 7100 in combination with Hypertension Management Software Client Server (HMS-CS) provides a derived
ascending aortic blood pressure waveform and a range of central arterial indices. Use of the Augmentation Index AIx only
is restricted to patients of age 40 and above.
It is used with a standard cuff blood pressure measurement.
It is used in those 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 as stated in the FDA summary.
https://510kreport.com/device/K140928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140928: ABPM7100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140928
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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