# K091224: Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-S

- Pathway: 510(k) (Special)
- Applicant: Somanetics Corp.
- Decided: Jul 9, 2009 after 73 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: 4 generations back to K001842 (2000). 4 ancestors in all.
49 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 1.

## Most influential descendants
- K112820: Fore-Sight Absolute Tissue Oximeter (2012), 47 descendants of its own
- K133879: Fore-Sight Elite Absolute Tissue Oximeter (2014), 44 descendants of its own
- K143675: FORE-SIGHT Elite Absolute Tissue Oximeter (2015), 37 descendants of its own
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own
- K180003: FORE-SIGHT ELITE Module Tissue Oximeter (2018), 29 descendants of its own

## Indications for use
The noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual.

Source page: https://510kreport.com/device/K091224
Methodology: https://510kreport.com/methodology