510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854265Substantially Equivalent

Simulator

Cygnus of South Florida, Inc., Hollywood FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854265 is the FDA 510(k) clearance record for SIMULATOR, a class I device, cleared for Cygnus of South Florida, Inc. on under FDA product code JQP (Calculator/Data Processing Module, For Clinical Use). FDA records list 2 510(k) clearances for Cygnus of South Florida, Inc., from to . As of , FDA records show no recalls naming K854265.

Clearance record

Decision date
Received
(146 days to decision)
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Regulation
21 CFR 862.2100
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Cygnus of South Florida, Inc. Emerald Hills Professional Pk, Hollywood FL
Third party review
No

Clearances, product code JQP

Trailing 12 months

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

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