# K140928: ABPM7100

- Pathway: 510(k) (Traditional)
- Applicant: I.E.M. GmbH
- Decided: Sep 15, 2014 after 157 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K950779 (1995). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110603: Hypertension Management Software Claient Server (HMS-CS), I.E.M. GmbH (2011) Summary page 5.

## Most influential descendants
- K151520: Oscar 2 (2016), 3 descendants of its own
- K210139: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (2021), 1 descendant of its own
- K251581: Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own
- K153557: ABPM 7100, Hypertension Management Software (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K140928
Methodology: https://510kreport.com/methodology