# MUD: Oximeter, Tissue Saturation

- Device class: 2; regulation: 21 CFR 870.2700; FDA's rule: 510(k) required
- FDA decisions: 74
- 510(k) review time 2021–2025: median 130 days (middle half 106–205)
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 3
- 2018: 3
- 2019: 7
- 2020: 2
- 2021: 2
- 2022: 2
- 2023: 2
- 2024: 5
- 2025: 2
- 2026: 1

## Most-cited predicates
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C (2009), cited by 10
- K051274: Invos System (2005), cited by 8
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303 (2004), cited by 7
- K102715: Regional Oximeter (2010), cited by 6
- K012759: Inspectra Tissue Spectrometer System (Inspectra), Model 325 (2002), cited by 5
- K080769: Invos Cerebral/Somatic Oximeter System, Model 5100C (2008), cited by 5
- K042657: Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 (2005), cited by 4
- K023938: Modification to Inspectra Tissue Spectrometer System, Model 325 (2002), cited by 4
- K112820: Fore-Sight Absolute Tissue Oximeter (2012), cited by 4
- K113656: Careguide Oximeter (2012), cited by 4

Source page: https://510kreport.com/product-code/MUD
Data by year (CSV): https://510kreport.com/product-code/MUD.csv