Cleared Traditional

K881000 - KERATINOCYTE GROWTH MEDIUM (KGM)

K881000 is the FDA 510(k) clearance for KERATINOCYTE GROWTH MEDIUM (KGM) by Clonetics Corp.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K881000 · Clonetics Corp. · Pathology device
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Mar 1988
Decision
13d
Days
Class 1
Risk

K881000 is an FDA 510(k) clearance for the KERATINOCYTE GROWTH MEDIUM (KGM). Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Clonetics Corp. (San Diego, US). The FDA issued a Cleared decision on March 21, 1988 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - the FDA pathology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clonetics Corp. devices

Submission Details

510(k) Number K881000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date March 21, 1988
Days to Decision 13 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 77d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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 - KIT Media And Components, Synthetic Cell And Tissue Culture

All 305
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K881000.
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2011
K882807 · J R Scientific · Jul 1988
RPMI-1640 MEDIUM, CATALOG NO. 200-2076
K882808 · J R Scientific · Jul 1988
EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM
K880691 · Sigma Chemical Co. · Mar 1988
MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI.
K873090 · Sigma Chemical Co. · Aug 1987
AMES' MEDIUM NO. A1420 W/L-GLUTA. W.O/SOD. BICARB.
K873091 · Sigma Chemical Co. · Aug 1987
RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU.
K873092 · Sigma Chemical Co. · Aug 1987