Cleared Traditional

K110407 - INVISIPORT

K110407 is an FDA 510(k) clearance for INVISIPORT, manufactured by Stealth Therapeutics, Incorporated. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K110407 · Stealth Therapeutics, Incorporated · General Hospital
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Oct 2011
Decision
241d
Days
Class 2
Risk

K110407 is an FDA 510(k) clearance for the INVISIPORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Stealth Therapeutics, Incorporated (Stoughton, US). The FDA issued a Cleared decision on October 13, 2011 after a review of 241 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 Stealth Therapeutics, Incorporated devices

FDA 510(k) Submission Details - K110407

510(k) Number K110407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date October 13, 2011
Days to Decision 241 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
112d slower than avg
Panel avg: 129d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 197
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K110407.
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