# HFX: Clamp, Circumcision

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 350 days (middle half 309–390)
- Recalls: 11 (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)
- 2004: 3
- 2005: 1
- 2007: 2
- 2010: 1
- 2012: 2
- 2013: 1
- 2015: 2
- 2022: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K032091: Smart Klamp Various by Size (2004), cited by 4
- K890897: Centurion Circlamp (1989), cited by 2
- K040052: Fine Surgical Circumcision Clamp (2004), cited by 1
- K151095: Circumplast Circumcision Device (2015), cited by 1
- K121789: Shangring (2012), cited by 1
- K935491: Centurion Mogen Clamp/Circumcision (Ster/Non Ster) (1994), cited by 1
- K033403: T.S. Medical Circumcision Clamp (2004), cited by 1
- K100916: Medicon Mogen Clamp (2010), cited by 1
- K894201: Gomco Circumcision Clamp (1989), cited by 1

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