# EXB: Collector, Ostomy

- Device class: 1; regulation: 21 CFR 876.5900; FDA's rule: 510(k) exempt
- FDA decisions: 102
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- Recalls: 5 (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)
- 1983: 5
- 1984: 17
- 1985: 10
- 1986: 7
- 1987: 8
- 1988: 3
- 1993: 1
- 2014: 1
- 2018: 1
- 2025: 1

## Most-cited predicates
- K140938: Ostom-I Alert (2014), cited by 2
- K821271: Bard Protective Barrier Film (1982), cited by 1
- K813269: Two Piece Ostomy System (1981), cited by 1
- K830945: Sur-Fit Flexible (1983), cited by 1
- K811240: Sur-Fit Loop Ostomy O.R. Set (1981), cited by 1

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