# K041313: Stabil-O-Graph

- Pathway: 510(k) (Traditional)
- Applicant: I.E.M. GmbH
- Decided: Jun 18, 2004 after 32 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: 1 generation back to K021682 (2002). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021682: Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773, Hem-773AC, Omron Healthcare, Inc. (2002). Our reading of the summary gave K021862, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “OMRON, Model HEM-711 (773 AC)”.

## Most influential descendants
- K053395: BP Pro Blood Pressure Monitor (2005), 1 descendant of its own
- K173895: Tel-O-Graph (2019), 0 descendants of its own
- K060703: PMP4 BP Pro Blood Pressure Monitor (2006), 0 descendants of its own

## Indications for use
The I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).

Source page: https://510kreport.com/device/K041313
Methodology: https://510kreport.com/methodology