# HIB: Speculum, Vaginal, Nonmetal

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) exempt
- FDA decisions: 72
- 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)
- 2006: 4
- 2007: 1
- 2008: 2
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 2
- 2026: 1

## Most-cited predicates
- K000414: Medisul Disposable Vaginal Speculum (2000), cited by 3
- K070964: Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System (2007), cited by 3
- K941272: Kleenspec (1994), cited by 3
- K050887: Gongdong Disposable Vaginal Speculum (2005), cited by 2
- K984211: Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303 (1998), cited by 2
- K091937: Office-Spec Disposable Side-Opening Speculum (2009), cited by 1
- K072762: Depalt Vaginal Specuim and Depalt Lighting System (2008), cited by 1
- K052314: Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large (2005), cited by 1
- K042950: Vag O Speculum, Models VS1, VM1, VL1 (2004), cited by 1
- K012535: DRG Disposable Vaginal Speculum (2002), cited by 1

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