# K032127: Hemedex Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Hemedex Incorporated
- Decided: Dec 30, 2003 after 173 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K914699 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914699: Uresil Fixation Device, Uresil Corp. (1992) Summary page 4.

## Indications for use
The Hemedex Fixation Device is intended to be used on the patient’s skin to secure the percutaneous placement of the QFlow Perfusion Probe.

Source page: https://510kreport.com/device/K032127
Methodology: https://510kreport.com/methodology