510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K873200Substantially Equivalent

Karlson Ozone Sterilizer Model 100B

Life Enhancement Technologies, LLC, Erie PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873200 is the FDA 510(k) clearance record for KARLSON OZONE STERILIZER MODEL 100B, a class II device, cleared for Life Enhancement Technologies, LLC on under FDA product code FLF (Sterilizer, Ethylene-Oxide Gas). FDA records list 3 510(k) clearances for Life Enhancement Technologies, LLC, from to . As of , FDA records show no recalls naming K873200.

Clearance record

Decision date
Received
(533 days to decision)
Product code
FLF Sterilizer, Ethylene-Oxide Gas
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
Life Enhancement Technologies, LLC 2926 State St., Erie PA
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