# K111007: Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest RE

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Reprocessing Center, LLC
- Decided: Jun 8, 2011 after 58 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 Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.

Source page: https://510kreport.com/device/K111007
Methodology: https://510kreport.com/methodology