Cleared Traditional

K831313 - TISSUE-TEK V.I.P. 100/200

K831313 is the FDA 510(k) clearance for TISSUE-TEK V.I.P. 100/200 by Miles Laboratories, Inc.. It is a Class 1 Pathology device (product code IEO) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K831313 · Miles Laboratories, Inc. · Pathology device
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Jul 1983
Decision
97d
Days
Class 1
Risk

K831313 is an FDA 510(k) clearance for the TISSUE-TEK V.I.P. 100/200. Classified as Processor, Tissue, Automated (product code IEO), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3875 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

Submission Details

510(k) Number K831313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1983
Decision Date July 28, 1983
Days to Decision 97 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
20d slower than avg
Panel avg: 77d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IEO Processor, Tissue, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3875
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 - IEO Processor, Tissue, Automated

Devices cleared under the same product code (IEO) and FDA review panel - the closest regulatory comparables to K831313.
LKB 2189 ULTROPROCESSOR
K843506 · Lkb Instruments, Inc. · Nov 1984
AUTOTECHNICON V TISSUE PROCESS SYS
K834599 · Technicon Instruments Corp. · Feb 1984
TISSUE-TEK III MINI-RAPID PROCESSOR
K801427 · Miles Laboratories, Inc. · Jul 1980
TISSUE-TEK III V.I.P.
K771308 · Miles Laboratories, Inc. · Aug 1977
HISTO-TEK W/ AUTOMATIC COVERSLIPPER
K761062 · Miles Laboratories, Inc. · Mar 1977