Cleared Traditional

K781868 - DROPPER

K781868 is the FDA 510(k) clearance for DROPPER by Marion Laboratories, Inc.. It is a Class 1 Microbiology device (product code KEQ) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K781868 · Marion Laboratories, Inc. · Microbiology device
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Nov 1978
Decision
19d
Days
Class 1
Risk

K781868 is an FDA 510(k) clearance for the DROPPER, CEPTI-SEAL LAVTOPHENOL. Classified as Media, Mounting, Water Soluble (product code KEQ), Class I - General Controls.

Submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.4010 - 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: 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 Marion Laboratories, Inc. devices

Submission Details

510(k) Number K781868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1978
Decision Date November 22, 1978
Days to Decision 19 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 102d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEQ Media, Mounting, Water Soluble
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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 - KEQ Media, Mounting, Water Soluble

Devices cleared under the same product code (KEQ) and FDA review panel - the closest regulatory comparables to K781868.
VASPAR SEALANT
K792702 · Meridian Diagnostics, Inc. · Jan 1980
LACTO-PHENOL ANALINE BLUE FLUID
K792703 · Meridian Diagnostics, Inc. · Jan 1980
KOH MOUNTING FLUID W/GLYCEROL
K792709 · Meridian Diagnostics, Inc. · Jan 1980
DROPPER, CEPTI-SEAL KOH SOLUTION
K781869 · Marion Laboratories, Inc. · Nov 1978
F.A. MOUNTING MEDIUM
K781388 · Flow Laboratories, Inc. · Aug 1978