Cleared Traditional

K991473 - SIRSCAN

K991473 is an FDA 510(k) clearance for SIRSCAN, manufactured by Intelligence Artificielle Applications. The device is a Class 1 Microbiology device with product code KZK cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K991473 · Intelligence Artificielle Applications · Microbiology device
Download Printable Device Report (PDF)
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Nov 1999
Decision
210d
Days
Class 1
Risk

K991473 is an FDA 510(k) clearance for the SIRSCAN. Classified as Reader, Zone, Automated (product code KZK), Class I - General Controls.

Submitted by Intelligence Artificielle Applications (Washington, US). The FDA issued a Cleared decision on November 23, 1999 after a review of 210 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2850 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K991473

510(k) Number K991473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1999
Decision Date November 23, 1999
Days to Decision 210 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 102d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

KZK Device Classification - Class 1, General Controls

Product Code KZK Reader, Zone, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2850
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.