510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921179Substantially Equivalent

Olympus-Keymed Disinfectant Fume Extractor Dfe-20

Keymed, Inc., Essex Ss2 5qh England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921179 is the FDA 510(k) clearance record for OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20, a class II device, cleared for Keymed, Inc. on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 29 510(k) clearances for Keymed, Inc., from to . As of , FDA records show no recalls naming K921179.

Clearance record

Decision date
Received
(385 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Keymed, Inc. Keymed House, Stock Rd., Essex Ss2 5qh England, GB
510(k) summary
Statement
Third party review
No

Clearances, product code FEB

Trailing 12 months

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

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