Cleared Traditional

K904499 - NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (FDA 510(k) Clearance)

Class I Microbiology device.

K904499 · Ackrad Laboratories · Microbiology device
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Jul 1991
Decision
273d
Days
Class 1
Risk

K904499 is an FDA 510(k) clearance for the NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM). Classified as Antiserum, Positive Control, Aspergillus Spp. (product code KFG), Class I - General Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on July 1, 1991 after a review of 273 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3040 - 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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Submission Details

510(k) Number K904499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1990
Decision Date July 01, 1991
Days to Decision 273 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KFG Antiserum, Positive Control, Aspergillus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3040
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.