510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904499Substantially Equivalent

Nicos (Non-Invasive Cardiac Output System)

Ackrad Laboratories, Cranford NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904499 is the FDA 510(k) clearance record for NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM), a class I device, cleared for Ackrad Laboratories on under FDA product code KFG (Antiserum, Positive Control, Aspergillus Spp.). FDA records list 42 510(k) clearances for Ackrad Laboratories, from to . As of , FDA records show no recalls naming K904499.

Clearance record

Decision date
Received
(273 days to decision)
Product code
KFG Antiserum, Positive Control, Aspergillus Spp.
Regulation
21 CFR 866.3040
Device class
Class I
Review panel
Microbiology
Applicant
Ackrad Laboratories 70 Jackson Dr., Cranford NJ
Third party review
No

Clearances, product code KFG

Trailing 12 months

FDA records hold no clearances under product code KFG in the trailing twelve months.

FDA records show no clearances under product code KFG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KFG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260