# MRH: Pump, Infusion, Ophthalmic

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 128 days (middle half 102–158)
- Recalls: 0 (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)
- 2005: 1
- 2013: 1
- 2014: 1
- 2017: 2
- 2020: 1
- 2021: 2
- 2022: 2
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K173332: OMNI Surgical System (2017), cited by 4
- K963434: Viscous Fluid System (1996), cited by 3
- K993039: Viscous Fluid Injector System Module (CX5700) (2000), cited by 2
- K171905: VISCO 360 Viscosurgical System (2017), cited by 2
- K202678: OMNI Surgical System (2021), cited by 1
- K143205: Viscoelastic Injector (2014), cited by 1
- K132494: Viscoelastic Injector (2013), cited by 1
- K972664: Storz Millennium Viscous Fluid System (1997), cited by 1
- K232214: OMNI Surgical System (2023), cited by 1
- K050716: Iscience Surgical Viscoinjector (2005), cited by 1

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