510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970249Substantially Equivalent

Simplex Airbrator

Simplex Medical Systems, Inc., Hallandale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970249 is the FDA 510(k) clearance record for SIMPLEX AIRBRATOR, a class II device, cleared for Simplex Medical Systems, Inc. on under FDA product code KOJ (Airbrush). FDA records list 3 510(k) clearances for Simplex Medical Systems, Inc., from to . As of , FDA records show no recalls naming K970249.

Clearance record

Decision date
Received
(105 days to decision)
Product code
KOJ Airbrush
Regulation
21 CFR 872.6080
Device class
Class II
Review panel
Dental
Applicant
Simplex Medical Systems, Inc. 430 Ansin Blvd., Hallandale FL
510(k) summary
Statement
Third party review
No

Clearances, product code KOJ

Trailing 12 months

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

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