# HNO: Keratome, Ac-Powered

- Device class: 1; regulation: 21 CFR 886.4370; FDA's rule: 510(k) required
- FDA decisions: 83
- Recalls: 9 (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)
- 2001: 6
- 2002: 9
- 2003: 5
- 2004: 11
- 2005: 3
- 2006: 2
- 2008: 1
- 2009: 1
- 2017: 1
- 2018: 1

## Most-cited predicates
- K972808: Hansatome Microkeratome (1997), cited by 7
- K913697: Automatic Corneal Shaper (1991), cited by 7
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) (1997), cited by 7
- K941550: Automatic Corneal Shaper Surgical Instrument (1994), cited by 5
- K010260: Hansatome Microkeratome (2001), cited by 4
- K980924: Plancon Microlamellar Keratome Evolution (1998), cited by 4
- K903912: Keratome (1990), cited by 3
- K962661: ML Microkeratome Blade (1996), cited by 3
- K032910: Carriazo Pendular (2004), cited by 3
- K960395: Plancon Mircolamellar Keratome (1996), cited by 3

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