Cleared Traditional

PRONTO DRY (K991248) - FDA 510(k) Clearance

Class I Microbiology device.

K991248 · Medical Instruments Corporation Mic AG · Microbiology device
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Jun 1999
Decision
71d
Days
Class 1
Risk

K991248 is an FDA 510(k) clearance for the PRONTO DRY. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Medical Instruments Corporation Mic AG (Solothurn, CH). The FDA issued a Cleared decision on June 22, 1999 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - 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 Medical Instruments Corporation Mic AG devices

Submission Details

510(k) Number K991248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date June 22, 1999
Days to Decision 71 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 102d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYR Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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.

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