Cleared Traditional

K852506 - BIOGLAS MICROCARRIER BEAD (FDA 510(k) Clearance)

Class I Pathology device.

K852506 · Solohill Engineering, Inc. · Pathology device
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Jul 1985
Decision
30d
Days
Class 1
Risk

K852506 is an FDA 510(k) clearance for the BIOGLAS MICROCARRIER BEAD. Classified as Apparatus, Roller (product code KJB), Class I - General Controls.

Submitted by Solohill Engineering, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2240 - 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 Solohill Engineering, Inc. devices

Submission Details

510(k) Number K852506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date July 12, 1985
Days to Decision 30 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 77d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJB Apparatus, Roller
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2240
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.