Cleared Traditional

K810613 - ANTIMICROBIAL REMOVAL DEVICE (FDA 510(k) Clearance)

Class I Microbiology device.

K810613 · Marion Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
28d
Days
Class 1
Risk

K810613 is an FDA 510(k) clearance for the ANTIMICROBIAL REMOVAL DEVICE. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on April 3, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - the FDA microbiology 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 Marion Laboratories, Inc. devices

Submission Details

510(k) Number K810613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1981
Decision Date April 03, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDB System, Blood Culturing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
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.