Cleared Traditional

K941098 - SECURE-SITE

K941098 is an FDA 510(k) clearance for SECURE-SITE, manufactured by Op-Co Medical Products , Ltd.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 518-day FDA review.

K941098 · Op-Co Medical Products , Ltd. · General Hospital
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Aug 1995
Decision
518d
Days
Class 1
Risk

K941098 is an FDA 510(k) clearance for the SECURE-SITE. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Op-Co Medical Products , Ltd. (New York City, US). The FDA issued a Cleared decision on August 9, 1995 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Op-Co Medical Products , Ltd. devices

FDA 510(k) Submission Details - K941098

510(k) Number K941098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1994
Decision Date August 09, 1995
Days to Decision 518 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
389d slower than avg
Panel avg: 129d · This submission: 518d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

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

All 14
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