# FMH: Container, Specimen, Sterile

- Device class: 1; regulation: 21 CFR 864.3250; FDA's rule: 510(k) exempt
- FDA decisions: 23
- Recalls: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1976: 1
- 1977: 4
- 1978: 4
- 1979: 4
- 1980: 6
- 1981: 1
- 1982: 1
- 1983: 1
- 1990: 1

## Most-cited predicates
- K800947: Midstream Collection Kit (1980), cited by 1

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