510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K991473Substantially Equivalent

Sirscan

Intelligence Artificielle Applications, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991473 is the FDA 510(k) clearance record for SIRSCAN, a class I device, cleared for Intelligence Artificielle Applications on under FDA product code KZK (Reader, Zone, Automated). FDA records list one 510(k) clearance for Intelligence Artificielle Applications. As of , FDA records show no recalls naming K991473.

Clearance record

Decision date
Received
(210 days to decision)
Product code
KZK Reader, Zone, Automated
Regulation
21 CFR 866.2850
Device class
Class I
Review panel
Microbiology
Applicant
Intelligence Artificielle Applications 1301k St., NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code KZK

Trailing 12 months

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

FDA records show no clearances under product code KZK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZK, 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