# FQM: Bandage, Elastic

- Device class: 1; regulation: 21 CFR 880.5075; FDA's rule: 510(k) exempt
- FDA decisions: 42
- Recalls: 12 (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)
- 1979: 5
- 1980: 11
- 1981: 2
- 1982: 3
- 1983: 2
- 1984: 2
- 1987: 1
- 1995: 1
- 2001: 1
- 2004: 2

## Most-cited predicates
- K013244: Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe (2001), cited by 1

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