# K955012: Mizuho Radiolucent Head Frame

- Pathway: 510(k) (Traditional)
- Applicant: Mizuho America, Inc.
- Decided: Sep 12, 1996 after 316 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Malcolm-Rand Radiolucent Headrest: named in the summary without a submission number
- (no number) Sugita Multi-Purpose Head Frame: named in the summary without a submission number

## Most influential descendants
- K083803: Fixit Headrest Clamp System (2010), 0 descendants of its own
- K090695: Dinkler Surgical Skull Clamp, Model 0308 (2009), 0 descendants of its own

## Indications for use
Clamping of a patient’s head and neck in a particular position during surgical procedures.

Source page: https://510kreport.com/device/K955012
Methodology: https://510kreport.com/methodology