# HBL: Holder, Head, Neurosurgical (Skull Clamp)

- Device class: 2; regulation: 21 CFR 882.4460; FDA's rule: 510(k) required
- FDA decisions: 50
- 510(k) review time 2021–2025: median 101 days (middle half 69–156)
- Recalls: 8 (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)
- 2011: 1
- 2012: 2
- 2013: 2
- 2014: 2
- 2017: 1
- 2019: 2
- 2020: 2
- 2021: 1
- 2024: 2
- 2025: 1

## Most-cited predicates
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components (2007), cited by 4
- K032331: Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy) (2003), cited by 3
- K923789: Mayfield Adult Disposable Skull Pin (1993), cited by 3
- K001808: Doro Headrest System (2000), cited by 3
- K932807: Mayfield* a-2000 Skull Clamp (1993), cited by 2
- K955012: Mizuho Radiolucent Head Frame (1996), cited by 2
- K953124: Mayfield Radiolucent 2000 Skull Clamp (1996), cited by 2
- K090506: Mayfield Infinity XR2 Skull Clamp, Model a-2114 (2009), cited by 2
- K051440: Mayfield Infinity Skull Clamp (2005), cited by 2
- K050319: Mayfield MR/CT Skull Clamp, Model 4-0-a-1104 (2005), cited by 2

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