# K001842: Adult/Pediatric Cerebral Oximeter, Model Invos 5100

- Pathway: 510(k) (Traditional)
- Applicant: Somanetics Corp.
- Decided: Sep 15, 2000 after 88 days
- Product code: DQA (Oximeter)
- 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
No predicates in its family tree.
85 later devices descend from it; 10 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051274: Invos System (2005), 76 descendants of its own
- K080769: Invos Cerebral/Somatic Oximeter System, Model 5100C (2008), 68 descendants of its own
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303 (2004), 67 descendants of its own
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C (2009), 66 descendants of its own
- K051257: Adult Cerebral Oximeter, Model 2040 (2005), 63 descendants of its own

Source page: https://510kreport.com/device/K001842
Methodology: https://510kreport.com/methodology