# MPA: Endoilluminator

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 270 days (middle half 232–291)
- Recalls: 1 (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)
- 2000: 2
- 2003: 1
- 2004: 1
- 2006: 2
- 2008: 1
- 2015: 2
- 2021: 1
- 2023: 1
- 2024: 2
- 2026: 1

## Most-cited predicates
- K970882: Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.) (1997), cited by 3
- K080067: Iscience Interventional Ophthalmic Microcatheter (2008), cited by 3
- K963417: Vitlite (TR7700) (1996), cited by 2
- K973293: Syntec True Light End Irrigating Endoilluminator (1997), cited by 2
- K151604: 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (2015), cited by 2
- K032598: Synergetics Synerlight Fiber Optic Lightsource (2003), cited by 2
- K980797: Peregrine Fiber Optic Multi-Function Manipulator (1998), cited by 2
- K973229: D.O.R.C. Hexon Illumination System (1997), cited by 2
- K964005: Synergetics Synerlight Fiber Optic Lightsource (1997), cited by 2
- K961036: Mbi Fiberoptic Endo-Illuminator (1996), cited by 2

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