# K052244: Iisis, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Innovision Medical Technologies, LLC
- Decided: Oct 13, 2005 after 57 days
- Product code: MOD (Accessory To Continuous Ventilator (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K011861 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011861: Bernoulli Ventilator Management System, Cardiopulmonary Corp. (2001)

## Indications for use
IISIS is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station and to provide remote monitoring and alarm surveillance. IISIS is intended to supplement and not replace any part of the current device monitoring procedures.

Source page: https://510kreport.com/device/K052244
Methodology: https://510kreport.com/methodology