# HHT: Spatula, Cervical, Cytological

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) required
- FDA decisions: 73
- Recalls: 0 (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)
- 2002: 1
- 2004: 2
- 2005: 1
- 2007: 1
- 2008: 2
- 2009: 1
- 2012: 1
- 2015: 1
- 2017: 1
- 2019: 1

## Most-cited predicates
- K861389: Pap Smear Kit (1986), cited by 3
- K971586: Digene Cervical Brush (1997), cited by 3
- K930955: Cervex-Brush (1994), cited by 3
- K832986: Pap Smear Brush (1984), cited by 2
- K874604: Histobrush (1988), cited by 1
- K915844: Exact-Touch (1994), cited by 1
- K896065: Wallach CC/Brush (1990), cited by 1
- K971849: Cytology Brush (1997), cited by 1
- K961934: Puritan Foam Tip Swab Model 2197 (1996), cited by 1
- K013258: Inpath E2 Collector (2002), cited by 1

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