# K141869: Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hemedex Incorporated
- Decided: Oct 10, 2014 after 91 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: 2 generations back to K974088 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032337: Hemedex Cranial Bolt Models, 3601, 3602, Hemedex Incorporated (2003) Summary page 4.
- 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 4.

## Indications for use
The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.

Source page: https://510kreport.com/device/K141869
Methodology: https://510kreport.com/methodology