# K032337: Hemedex Cranial Bolt Models, 3601, 3602

- Pathway: 510(k) (Traditional)
- Applicant: Hemedex Incorporated
- Decided: Oct 21, 2003 after 84 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974088 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992591: Codman Single and Double Lumen Skull Bolt Kits, Codman & Shurtleff, Inc. (1999) Summary page 1.
- K974088: Codman Intracranial Bolt, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K002765: Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe, Integra Neurosciences (2000) Summary page 1.
- (no number) Codman Disposable ICP Kit with Stainless Steel Screw: named in the summary without a submission number

## Most influential descendants
- K141869: Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit (2014), 0 descendants of its own

## Indications for use
The Hemedex Single and Double Lumen Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.

Source page: https://510kreport.com/device/K032337
Methodology: https://510kreport.com/methodology