510(k) · Cleared
ClearedEasydex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vineland Syrup, Inc. · MRV Drink, Glucose Tolerance
Cleared on Jun 21, 2012 as substantially equivalent to K032753 (Perk Scientific, Inc., 2003) after a 146-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jun 21, 2012
- Review
- 146 days
- Class
- Class II
- Product code
- MRV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032753 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK032753 Glucose Tolerance BeveragePerk Scientific, Inc. · 2003
- This deviceK120247 EasydexVineland Syrup, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032753 | Glucose Tolerance Beverage | Perk Scientific, Inc. | 2003 | — |
| 0 (this device) | K120247 | Easydex | Vineland Syrup, Inc. | 2012 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032753 | Glucose Tolerance BeverageSummary page 1…tion #*: 862.1345 Device to Which Substantial Equivalence is Claimed Glucose Tolerance Beverage Perk Scientific, Inc. 520 Commerce Dr. Yeadon, PA 19050 510(k) Numb er: K032753 Device Descripion EasyDeX is a water-based flavored beverage containing specific quantities of dextrose (d-glucose). The produc… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MRV devicesMRV Drink, Glucose Tolerance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MRV
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · MRV
Too few MRV 510(k)s in any year since 2007 to give a median.
Recalls per year · MRV
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRV
1in 2025
MAUDE reports naming product code MRV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 2 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120247 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120247: Easydex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120247
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026