510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905119Substantially Equivalent

Plazlyte(tm)

Abtox, Inc., Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905119 is the FDA 510(k) clearance record for PLAZLYTE(TM), a class II device, cleared for Abtox, Inc. on under FDA product code FLF (Sterilizer, Ethylene-Oxide Gas). FDA records list 3 510(k) clearances for Abtox, Inc. As of , FDA records show no recalls naming K905119.

Clearance record

Decision date
Received
(1,499 days to decision)
Product code
FLF Sterilizer, Ethylene-Oxide Gas
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
Abtox, Inc. 104 Ter. Dr., Mundelein IL
Third party review
No

Clearances, product code FLF

Trailing 12 months

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

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