510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810542Substantially Equivalent

Cement Fume Evacuator Tank & Filter

Walgen Medical Innoventions, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810542 is the FDA 510(k) clearance record for CEMENT FUME EVACUATOR TANK & FILTER, a class I device, cleared for Walgen Medical Innoventions on under FDA product code JDY (Evacuator, Vapor, Cement Monomer). FDA records list 3 510(k) clearances for Walgen Medical Innoventions, from to . As of , FDA records show no recalls naming K810542.

Clearance record

Decision date
Received
(14 days to decision)
Product code
JDY Evacuator, Vapor, Cement Monomer
Regulation
21 CFR 888.4220
Device class
Class I
Review panel
Orthopedic
Applicant
Walgen Medical Innoventions 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JDY

Trailing 12 months

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

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