Cleared Traditional

K083081 - MODIFICATION TO SECURACATH

K083081 is an FDA 510(k) clearance for MODIFICATION TO SECURACATH, manufactured by Interrad Medical, Inc.. The device is a Class 2 General Hospital device with product code OKC cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K083081 · Interrad Medical, Inc. · General Hospital
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Mar 2009
Decision
139d
Days
Class 2
Risk

K083081 is an FDA 510(k) clearance for the MODIFICATION TO SECURACATH, MODEL: SPK01. Classified as Implanted Subcutaneous Securement Catheter (product code OKC), Class II - Special Controls.

Submitted by Interrad Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 4, 2009 after a review of 139 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Interrad Medical, Inc. devices

FDA 510(k) Submission Details - K083081

510(k) Number K083081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2008
Decision Date March 04, 2009
Days to Decision 139 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 129d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OKC Device Classification - Class 2, Special Controls

Product Code OKC Implanted Subcutaneous Securement Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
Definition Access To Central Venous System For Blood Sampling And Infusion, And To Provide A Means To Secure The Catheter Via A Subcutaneous Anchor Below The Insertion Site.
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 General Hospital devices follow this clearance model.