# K202189: Graffiti

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Dec 8, 2020 after 126 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 36 generations back to K941811 (1994). 268 ancestors in all.
No later device cites it as a predicate yet.
2 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180534: Philips IntelliVue GuardianSoftware, Philips Medizin Systeme Boeblingen GmbH (2018) Summary page 4.

## Indications for use
Graffiti is a software solution that includes integrated team collaboration tools and a smart assistant for the retrieval and display of patient record information and data whenever needed by a Healthcare Provider (HCP). The smart assistant also includes analytical functions to enable user-defined notifications. When the Parameter-Based Notification feature is enabled, the smart assistant is also intended to keep track of changes in patient information, data and status. Graffiti may be used by members of the patient care team while on duty physically at the hospital or while on call, which could be remotely. Graffiti is not intended to replace the Electronic Medical Record system or any patient monitoring or central station devices.

Source page: https://510kreport.com/device/K202189
Methodology: https://510kreport.com/methodology