Cleared Traditional

K931383 - ZINC PVA

K931383 is the FDA 510(k) clearance for ZINC PVA by Remel Co.. It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K931383 · Remel Co. · Microbiology device
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Jun 1993
Decision
89d
Days
Class 1
Risk

K931383 is an FDA 510(k) clearance for the ZINC PVA. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Remel Co. devices

Submission Details

510(k) Number K931383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1993
Decision Date June 15, 1993
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 16
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K931383.
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K013711 · Remel Co. · Nov 2001
MID-STREAM COLLECTION SET-STERILE
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PARA-PAK PLUS
K931770 · Meridian Diagnostics, Inc. · Jun 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · Proteins Intl., Inc. · Jan 1993
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991