# K153557: ABPM 7100, Hypertension Management Software

- Pathway: 510(k) (Traditional)
- Applicant: I.E.M. GmbH
- Decided: Jul 19, 2016 after 218 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: 7 generations back to K950779 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140928: ABPM7100, I.E.M. GmbH (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K153557
Methodology: https://510kreport.com/methodology