Cleared Traditional

K831450 - DISPOSABLE STERILE FILTER SYSTEM

K831450 is the FDA 510(k) clearance for DISPOSABLE STERILE FILTER SYSTEM by Corning Medical & Scientific. It is a Class 1 Pathology device (product code LIB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K831450 · Corning Medical & Scientific · Pathology device
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Jun 1983
Decision
28d
Days
Class 1
Risk

K831450 is an FDA 510(k) clearance for the DISPOSABLE STERILE FILTER SYSTEM. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Corning Medical & Scientific (Walker, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.2660 - 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K831450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1983
Decision Date June 02, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 77d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - LIB Device, General Purpose, Microbiology, Diagnostic

All 13
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K831450.
STRIPREADER MICROELISA SYSTEM
K831643 · Organon Teknika Corp. · Jul 1983
MICROELISA COMP
K831658 · Organon Teknika Corp. · Jul 1983
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
K831448 · R&D Systems, Inc. · Jun 1983
DISPOSABLE DISPENSING-SPREAD PIPETS
K822292 · American Dade · Aug 1982
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY
K820043 · American Dade · Jan 1982