# GIO: Tube, Collection, Capillary Blood

- Device class: 1; regulation: 21 CFR 864.6150; FDA's rule: 510(k) exempt
- FDA decisions: 22
- Recalls: 22 (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)
- 1977: 1
- 1981: 5
- 1983: 1
- 1984: 4
- 1985: 1
- 1987: 1
- 1988: 4
- 1989: 3
- 1994: 1
- 1997: 1

## Most-cited predicates

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