# HMY: Keratome, Battery-Powered

- Device class: 1; regulation: 21 CFR 886.4370; FDA's rule: 510(k) required
- FDA decisions: 12
- Recalls: 2 (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)
- 1978: 1
- 1990: 1
- 1998: 2
- 1999: 2
- 2000: 1
- 2001: 1
- 2002: 3
- 2004: 1

## Most-cited predicates
- K002191: Carriazo Barraquer II Microkeratome (2000), cited by 7
- K981741: Carriazo Barraquer Microkeratome (1998), cited by 3
- K984537: Keratome System, Model K3000 (1999), cited by 2
- K003594: Carriazo Barraquer Single Use Microkeratome (2001), cited by 1
- K022637: BD-3000 Microkeratome System, Model K-3000 Microkeratome (2002), cited by 1
- K023092: BD K-4000 Microkeratome System (2002), cited by 1
- K040297: Oneuse- Plus Microkeratome (2004), cited by 1

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