Cleared Traditional

ILS(TM) - INVASIVE LINE SEPARATOR (K924369) - FDA 510(k) Clearance

Class I General Hospital device.

K924369 · 2-Rn Corp. · General Hospital
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Feb 1993
Decision
161d
Days
Class 1
Risk

K924369 is an FDA 510(k) clearance for the ILS(TM) - INVASIVE LINE SEPARATOR. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by 2-Rn Corp. (Melbourne, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 161 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all 2-Rn Corp. devices

Submission Details

510(k) Number K924369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1992
Decision Date February 05, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMK Device, Intravascular Catheter Securement

Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K924369.
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
K180994 · Interrad Medical, Inc. · Jul 2019
IAB ANCHOR
K922103 · Datascope Corp. · Aug 1993
DESERET POSITIONAL SUTURE WING
K915495 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
ADHESIVE I.V. CATHETER DRESSING
K810579 · Johnson & Johnson Professionals, Inc. · Mar 1981