# K100523: Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM, HHS-SPFB-Usa

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: May 4, 2010 after 69 days
- Product code: NMD (Oximeter, Tissue Saturation, Reprocessed)
- 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). 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)
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 1.
- K080769: Invos Cerebral/Somatic Oximeter System, Model 5100C, Somanetics Corp. (2008) Summary page 1.
- K051274: Invos System, Somanetics Corp. (2005) Summary page 1.
- K001842: Adult/Pediatric Cerebral Oximeter, Model Invos 5100, Somanetics Corp. (2000)
- K971628: Somanetics Invos 3100A Cerebral Oximeter (Invos), Somanetics Corp. (1997) Summary page 1.
- K960614: Somanetics Invos 3100A Cerebral Oximeter (Invos), Somanetics Corp. (1996) Summary page 1.

## Indications for use
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somnatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 51OOC and is intended to be used with the Cerebral/Somatic Oximeter, Model 51 OOC only. The noninvasive 5 100C Cerebral/Somatic Oximeter is 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. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from thie IOOC Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 51OOC Cerebral/Somnatic Oximeter should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K100523
Methodology: https://510kreport.com/methodology