Cleared Traditional

K911613 - VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911613 · Exmoor Plastics , Ltd. · Toxicology device
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Jun 1991
Decision
86d
Days
Class 2
Risk

K911613 is an FDA 510(k) clearance for the VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on June 28, 1991 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - the FDA toxicology 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 Exmoor Plastics , Ltd. devices

Submission Details

510(k) Number K911613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date June 28, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 87d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCR Fluorescent Immunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.