# K173895: Tel-O-Graph

- Pathway: 510(k) (Traditional)
- Applicant: I.E.M. Industrielle Entwicklung and Medizintechnik
- Decided: May 16, 2019 after 511 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: 2 generations back to K021682 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041313: Stabil-O-Graph, I.E.M. GmbH (2004) Summary page 4.

## Indications for use
The Tel-O-Graph is intended for the home measurement of blood pressure and pulse on the upper arm in adults. The blood pressure monitor is suitable for individuals with an arm circumference of 20-55 cm (7.9-21.7 in) when used with the corresponding monitor cuff size. The data measured is automatically transmitted.

Source page: https://510kreport.com/device/K173895
Methodology: https://510kreport.com/methodology