Cleared Traditional

K904499 - NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)

K904499 is an FDA 510(k) clearance for NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM), manufactured by Ackrad Laboratories. The device is a Class 1 Microbiology device with product code KFG cleared through the Traditional 510(k) pathway after a 273-day FDA review.

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.

View all Ackrad Laboratories devices

FDA 510(k) Submission Details - K904499

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

KFG Device Classification - Class 1, General Controls

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.

Regulatory Peers - KFG Antiserum, Positive Control, Aspergillus Spp.

Devices cleared under the same product code (KFG) and FDA review panel - the closest regulatory comparables to K904499.
ASPERGILLUS SP, ANTISERUM POSITIVE
K792686 · Meridian Diagnostics, Inc. · Jan 1980
ASPERGILLUS SP, ANTISERUM, POSITIVE
K792698 · Meridian Diagnostics, Inc. · Jan 1980
ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
K791386 · Immuno-Mycologics, Inc. · Aug 1979
ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)
K760835 · I M, Inc. · Nov 1976