Cleared Traditional

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (K100518) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100518 · Instrumed International, Inc. · Cardiovascular device
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Aug 2010
Decision
189d
Days
Class 2
Risk

K100518 is an FDA 510(k) clearance for the INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054. Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 31, 2010 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumed International, Inc. devices

Submission Details

510(k) Number K100518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2010
Decision Date August 31, 2010
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWP Dilator, Vessel, Surgical

All 19
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K100518.
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · Fehling Surgical Instruments, Inc. · Apr 2023
Geomed Vascular Dilators
K183438 · Geomed Medizin-Technik GmbH & Co. · Sep 2019
FOGARTY VESSEL CALIBRATOR
K902143 · Baxter Healthcare Corp · Oct 1990
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983