Cleared Traditional

GELRITE (K820610) - FDA 510(k) Clearance

Class I Microbiology device.

K820610 · Kelco · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
233d
Days
Class 1
Risk

K820610 is an FDA 510(k) clearance for the GELRITE. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Kelco (Walker, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 233 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kelco devices

Submission Details

510(k) Number K820610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date October 27, 1982
Days to Decision 233 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 102d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSK Supplement, Culture Media

All 13
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K820610.
HEMOGLOBIN POWDER
K881566 · Acumedia Manufacturers, Inc. · Apr 1988
ABBOTT CATION SUPPLEMENT SOLUTION
K853546 · Abbott Laboratories · Sep 1985
LACTOSE
K833210 · Acumedia Manufacturers, Inc. · Oct 1983
GELYSATE
K811649 · Acumedia Manufacturers, Inc. · Jul 1981
POLYPEPTONE PEPTONE
K811652 · Acumedia Manufacturers, Inc. · Jul 1981
PHYTONE
K811653 · Acumedia Manufacturers, Inc. · Jul 1981