# K100518: Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054

- Pathway: 510(k) (Traditional)
- Applicant: Instrumed International, Inc.
- Decided: Aug 31, 2010 after 189 days
- Product code: DWP (Dilator, Vessel, Surgical)
- Device class: 2
- Regulation: 21 CFR 870.4475
- 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 K030788 (2003). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K030788: Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators, Geister Medizin Technik GmbH (2003) Summary page 1.

## Most influential descendants
- K183438: Geomed Vascular Dilators (2019), 1 descendant of its own
- K220981: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (2023), 0 descendants of its own
- K163524: Vessel Dilator (2017), 0 descendants of its own

## Indications for use
INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to Perform various manoeuvres of dilation and measurement of annulus and lumen diameters

Source page: https://510kreport.com/device/K100518
Methodology: https://510kreport.com/methodology