# Somanetics Corp.

- Location (FDA's records): Troy, MI
- FDA decisions: 12 (1990–2010): 12 510(k) clearances
- Product codes: DQA (4), MUD (4), DXZ (3), MWI (1)
- Predicates its devices cite: 10 (6 its own); citations of its devices by later devices: 47 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Icu Datasystems, Inc.: 1 (https://510kreport.com/company/icu-datasystems)
- Nellcor, Inc.: 1 (https://510kreport.com/company/nellcor)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Chase Medical, Inc.: 1 (https://510kreport.com/company/chase-medical)

## Firms that cite its devices most
- Cas Medical Systems, Inc.: 17 (https://510kreport.com/company/cas-medical-systems)
- Hygia Health Services, Inc.: 6 (https://510kreport.com/company/hygia-health-services)
- Midwest Reprocessing Center, LLC: 6 (https://510kreport.com/company/midwest-reprocessing-center)
- Covidien: 3 (https://510kreport.com/company/covidien)
- Nonin Medical, Inc.: 2 (https://510kreport.com/company/nonin-medical)
- Reflectance Medical, Inc.: 1 (https://510kreport.com/company/reflectance-medical)
- Spectros Corporation: 1 (https://510kreport.com/company/spectros)
- Mespere Lifesciences, Inc.: 1 (https://510kreport.com/company/mespere-lifesciences)

## Its most-cited devices
- K001842: Adult/Pediatric Cerebral Oximeter, Model Invos 5100 (2000), cited by 10
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C (2009), cited by 10
- K960614: Somanetics Invos 3100A Cerebral Oximeter (Invos) (1996), cited by 8
- K051274: Invos System (2005), cited by 8
- K080769: Invos Cerebral/Somatic Oximeter System, Model 5100C (2008), cited by 5
- K971628: Somanetics Invos 3100A Cerebral Oximeter (Invos) (1997), cited by 2

## Recent decisions
- K093422: Vital Sync Model 5000 Series (Apr 29, 2010)
- K091224: Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-S (Jul 9, 2009)
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C (Apr 3, 2009)
- K080769: Invos Cerebral/Somatic Oximeter System, Model 5100C (May 14, 2008)
- K051274: Invos System (Nov 4, 2005)
- K040162: Correstore Patch System (Mar 16, 2004)
- K031586: Correstore Patch System (Aug 7, 2003)
- K011487: Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS (Nov 21, 2001)

Source page: https://510kreport.com/company/somanetics