Cleared Traditional

K812558 - TISSUE-TEK III ACCU-CUT ROTARY MICROTOME (FDA 510(k) Clearance)

Class I Hematology device.

K812558 · Miles Laboratories, Inc. · Hematology device
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Sep 1981
Decision
21d
Days
Class 1
Risk

K812558 is an FDA 510(k) clearance for the TISSUE-TEK III ACCU-CUT ROTARY MICROTOME. Classified as Microtome, Rotary (product code IDO), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.3010 - the FDA hematology 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K812558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1981
Decision Date September 29, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IDO Microtome, Rotary
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
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.