# FPA: Set, Administration, Intravascular

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 1,178
- 510(k) review time 2021–2025: median 223 days (middle half 138–279)
- Recalls: 839 (17 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: 17
- 2018: 4
- 2019: 7
- 2020: 10
- 2021: 13
- 2022: 14
- 2023: 14
- 2024: 7
- 2025: 11
- 2026: 5

## Most-cited predicates
- K970855: Clave Connector (1997), cited by 15
- K944692: C-Series Homepump (1995), cited by 10
- K101677: Hospira Infusion Blood Sets (2010), cited by 8
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set (1997), cited by 8
- K032854: Unomedical Monica Infusion Set (2003), cited by 8
- K993848: Millennium Huber Plus Safety Infusion Set (2000), cited by 7
- K915571: Clave Connector (1992), cited by 7
- K955585: V2 Injection Site (1996), cited by 7
- K961794: Fluid Administration Set - Contrast Manager (1996), cited by 6
- K011071: Paradigm Quick-Set Infusion Set (2001), cited by 6

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