Cleared Traditional

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

K831313 is an FDA 510(k) clearance for TISSUE-TEK V.I.P. 100/200, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Pathology device with 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

FDA 510(k) Submission Details - K831313

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.

IEO Device Classification - Class 1, General Controls

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

All 10
Devices cleared under the same product code (IEO) and FDA review panel - the closest regulatory comparables to K831313.
LX120 TISSUE PROCESSOR
K851054 · Innovative Medical Systems, Inc. · May 1985
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 PROCESSING SYSTEM
K801513 · Innovative Medical Systems, Inc. · Jul 1980
TISSUE-TEK III V.I.P.
K771308 · Miles Laboratories, Inc. · Aug 1977