510(k) Report

510(k) · Cleared

Cleared

Direct Glucose Reagent Set

K841054510(k) TraditionalCleared May 1, 198450-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

Medical Specialties, Inc. · CGE Orthotoluidine, Glucose

Cleared on May 1, 1984 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 1, 1984
Review
50 days
Class
Class II
Product code
CGE
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K841054Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All CGE devices

CGE Orthotoluidine, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGE

FDA has decided no CGE device since 2007.

Median 510(k) review, days · CGE

Too few CGE 510(k)s in any year since 2007 to give a median.

Recalls per year · CGE

No recall names CGE since 2007.

Adverse event reports per year · CGE

No MAUDE report names CGE since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Medical Specialties, Inc.

40 FDA decisions under this applicant name. See the company

  • K946201Stand, InfusionMedical Specialties, Inc. · 1995
  • K931947CheckpointMedical Specialties, Inc. · 1993
  • K926095Refractrol-SPMedical Specialties, Inc. · 1993
  • K924926Msi-HCTMedical Specialties, Inc. · 1993
  • K896566Modified Fox Extra Gram Negative and PositiveMedical Specialties, Inc. · 1990

Recent decisions in CGE

The CGE category page

  • K890335Sodium Hydroxide Solution, Creatinine Reag./Dilu.Alpkem Corp. · 1989
  • K855185Glucose Reagent SetTechnostics Intl. · 1986
  • K850930GlucoseDilab, Inc. · 1985
  • K821198Direct Glucose Reagent SetOmega Medical Electronics · 1982
  • K811883King Diagnostics Glucose-O TestKing Diagnostics, Inc. · 1981

https://510kreport.com/device/K841054 · printed Nov 5, 2026

Cite this page

510(k) Report. “K841054: Direct Glucose Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K841054

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026