Cleared Traditional

K083081 - MODIFICATION TO SECURACATH, MODEL: SPK01 (FDA 510(k) Clearance)

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

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

Submission Details

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
11d slower than avg
Panel avg: 128d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.