# K012256: Gelbish Vascular Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Vascumetrix, LLC
- Decided: Dec 20, 2001 after 155 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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 K974617 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974617: Peripheral Vascular Dilator, Endovascular Instruments, Inc. (1998) Summary page 2.

## Most influential descendants
- K030260: Gelbfish Flex Vascular Dilator (2003), 0 descendants of its own
- K023507: Modification to Gelbfish Vascular Dilators (2002), 0 descendants of its own

## Indications for use
The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.

Source page: https://510kreport.com/device/K012256
Methodology: https://510kreport.com/methodology