510(k) Report

510(k) · Cleared

Cleared

Glucose Tolerance Beverage

K032753510(k) TraditionalCleared Nov 18, 200374-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Perk Scientific, Inc. · MRV Drink, Glucose Tolerance

Cleared on Nov 18, 2003 after a 74-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Nov 18, 2003
Review
74 days
Class
Class II
Product code
MRV
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared200020052010201520202025
  1. This deviceK032753 Glucose Tolerance BeveragePerk Scientific, Inc. · 2003
  2. Descendant · cites it directly · 0 of its ownK120247 EasydexVineland Syrup, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K120247EasydexVineland Syrup, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032753Glucose Tolerance BeveragePerk Scientific, Inc.2003—
+1K120247EasydexVineland Syrup, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K032753, 2003–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—Trutol, Glucose Tolerance Test Beverage
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120247EasydexVineland Syrup, Inc.20120

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?

  • Of its descendants, K120247 (Vineland Syrup, Inc., 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MRV devices

MRV Drink, Glucose Tolerance: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRV

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

2008: 12016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MRV

1in 2025

2008: 32016: 12019: 22024: 12025: 1
2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code MRV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—13
20090—00
20100—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—21
20170—00
20180—00
20190—02
20200—00
20210—00
20220—00
20230—00
20240—01
20250—01
20260—0—

What is it indicated for?

As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K032753: 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/K032753

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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