# K232385: OxiplexTS200

- Pathway: 510(k) (Traditional)
- Applicant: Iss Medical, Inc.
- Decided: Mar 1, 2024 after 205 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: 7 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)
- K100915: Inspectra STO2 Tissue Oxygenation Monitor, Model 650, Hutchinson Technology, Inc. (2010) Summary page 5.
- K042657: Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2, Vioptix, Inc. (2005) Summary page 5.

## Indications for use
The OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics, laboratories and outpatient facilities. The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.

Source page: https://510kreport.com/device/K232385
Methodology: https://510kreport.com/methodology