Cleared Traditional

FOAM RING PORT PROTECTOR (K062261) - FDA 510(k) Clearance

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

K062261 · Inspired Ideas, Incorporated · General Hospital
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Apr 2007
Decision
248d
Days
Class 2
Risk

K062261 is an FDA 510(k) clearance for the FOAM RING PORT PROTECTOR. Classified as Port, Protector/cushion (product code OBK), Class II - Special Controls.

Submitted by Inspired Ideas, Incorporated (Carmel, US). The FDA issued a Cleared decision on April 9, 2007 after a review of 248 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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 Inspired Ideas, Incorporated devices

Submission Details

510(k) Number K062261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2006
Decision Date April 09, 2007
Days to Decision 248 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
119d slower than avg
Panel avg: 129d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBK Port, Protector/cushion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
Definition Intended To Cushion And Protect The Localized Area Surrounding The Implanted Port And Indicated For Subjects Having Implanted Subcutaneous Or Intravascular Infusion Ports.
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.