Cleared Traditional

K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (K935252) - FDA 510(k) Clearance

Class I General Hospital device.

K935252 · K-Lok, Inc. · General Hospital
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Feb 1994
Decision
134d
Days
Class 1
Risk

K935252 is an FDA 510(k) clearance for the K-LOK CATHETER SECUREMENT DEVICE MODIFICATION. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by K-Lok, Inc. (Boca Raton, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 134 days - within the typical 510(k) review window.

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 K-Lok, Inc. devices

Submission Details

510(k) Number K935252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1993
Decision Date February 18, 1994
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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 K935252.
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