# K941558: Mayfield Child Disposable Skull Pin

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Dec 6, 1995 after 615 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; 1 cites 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K193438: DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (2020), 1 descendant of its own
- K241883: DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs)  (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs)  (3006-50) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K941558
Methodology: https://510kreport.com/methodology