510(k) · Cleared
Recalled · Class II · 2016Glucose Tolerance Beverage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Scientific · MRV Drink, Glucose Tolerance
Cleared on Oct 27, 2004 after a 77-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Oct 27, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- MRV
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | GTB, Glucose Tolerance Beverage Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2016 | Class II | Z-0330-2017 | Unknown/Undetermined by firm | Out of Specification Microbiological test results |
| Aug 24, 2016 | Class II | Z-0329-2017 | Unknown/Undetermined by firm | Out of Specification Microbiological test results |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MRV devicesMRV Drink, Glucose Tolerance: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Glucose Drink is a flavored beverage containing specific amounts of dextrose (D-glucose). Manufactured beverages contain three different amounts of glucose; 50,75, and 100 grams quantities per 10 oz bottle. This product is consumed in the In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and other related illnesses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042183: Glucose Tolerance Beverage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042183
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026