Cleared Abbreviated

VIROCULT, MODEL MW950 (K082472) - FDA 510(k) Clearance

Class I Microbiology device.

K082472 · Medical Wire & Equipment Company (Bath), Ltd. · Microbiology device
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Dec 2008
Decision
124d
Days
Class 1
Risk

K082472 is an FDA 510(k) clearance for the VIROCULT, MODEL MW950. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Medical Wire & Equipment Company (Bath), Ltd. (Corsham, Wiltshire, GB). The FDA issued a Cleared decision on December 30, 2008 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medical Wire & Equipment Company (Bath), Ltd. devices

Submission Details

510(k) Number K082472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2008
Decision Date December 30, 2008
Days to Decision 124 days
Submission Type Abbreviated
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 102d · This submission: 124d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.