510(k) Report

510(k) · Cleared

Cleared

Direct Glucose Reagent Set

K821198510(k) TraditionalCleared Jul 13, 198277-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

Omega Medical Electronics · CGE Orthotoluidine, Glucose

Cleared on Jul 13, 1982 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 13, 1982
Review
77 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 K821198Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in CGE? 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
Get a 510(k) Report

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 Omega Medical Electronics

21 FDA decisions under this applicant name. See the company

  • K823691Phosphorus Reagent SetOmega Medical Electronics · 1983
  • K821206SGPT-UV Reagent SetOmega Medical Electronics · 1982
  • K821204Glucose (Enzymatic) Reagent SetOmega Medical Electronics · 1982
  • K821212Urea Nitrogen Reagent SetOmega Medical Electronics · 1982
  • K821205Triglyceride Reagent SetOmega Medical Electronics · 1982

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
  • K841054Direct Glucose Reagent SetMedical Specialties, Inc. · 1984
  • K811883King Diagnostics Glucose-O TestKing Diagnostics, Inc. · 1981

https://510kreport.com/device/K821198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K821198: Direct Glucose Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K821198

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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