# FOS: Catheter, Umbilical Artery

- Device class: 2; regulation: 21 CFR 880.5200; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 318 days (middle half 318–318)
- 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)
- 1992: 2
- 1994: 7
- 1995: 5
- 1996: 1
- 1998: 1
- 2008: 2
- 2009: 2
- 2012: 1
- 2013: 1
- 2021: 1

## Most-cited predicates
- K940870: Umbili-Cath (1994), cited by 1
- K073596: Neomed Single Lumen Umbilical Catheter (2008), cited by 1
- K850884: Argyle Polyurethane Umbilical Vessel Catheter (1985), cited by 1
- K940871: Umbili-Cath-P (1994), cited by 1
- K130725: Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR. (2013), cited by 1

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