# K171245: Presygen/si-1

- Pathway: 510(k) (Traditional)
- Applicant: Christie Medical Holdings, Inc.
- Decided: Aug 9, 2018 after 468 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963903 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113507: Kent Camera, Kent Imaging, Inc. (2012) Summary page 4.

## Indications for use
Presygen™/si-1 is indicated for use in hospital facilities, along with clinical assessment of signs and symptoms, by healthcare professionals for non-invasive and non-diagnostic measure of relative temporal variation in oxygen saturation (StO2) in superficial tissue. Presygen™/si-1 displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports tissue oxygenation measurements in selected tissue regions. Presygen™/si-1 is intended for adults only (22 and over).

Source page: https://510kreport.com/device/K171245
Methodology: https://510kreport.com/methodology