510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100518Substantially Equivalent

Instrumed Vessel Dilators, Model 65-7Xx,65-9Xxx,66-1Xxx,65-7048-65-7054

Instrumed International Inc dba Avalign German Specialty Instruments, Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100518 is the FDA 510(k) clearance record for INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054, a class II device, cleared for Instrumed International, Inc. on under FDA product code DWP (Dilator, Vessel, Surgical). FDA records list 7 510(k) clearances for Instrumed International Inc dba Avalign German Specialty Instruments, from to . As of , FDA records show no recalls naming K100518.

Clearance record

Decision date
Received
(189 days to decision)
Product code
DWP Dilator, Vessel, Surgical
Regulation
21 CFR 870.4475
Device class
Class II
Review panel
Cardiovascular
Applicant
Instrumed International, Inc. 626 Cooper Ct., Schaumburg IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWP

Trailing 12 months

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

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