# K120247: Easydex

- Pathway: 510(k) (Traditional)
- Applicant: Vineland Syrup, Inc.
- Decided: Jun 21, 2012 after 146 days
- Product code: MRV (Drink, Glucose Tolerance)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 K032753 (2003). 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)
- K032753: Glucose Tolerance Beverage, Perk Scientific, Inc. (2003) Summary page 1.

## Indications for use
EasyDeX is a flavored non-carbonated beverage containing specific quantities of dextrose (0-glucose). The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle. This product is used in the administration of an in Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and other related disease conditions. This product is for oral consumption only.

Source page: https://510kreport.com/device/K120247
Methodology: https://510kreport.com/methodology