Cleared Traditional

K110424 - DIGNITY MINI PORT- ATTACHABLE (FDA 510(k) Clearance)

Also includes:
DIGNITY MINI PORT- PRE ATTACHED DIGNITY LOW PROFILE PORT- ATTACHABLE DIGNITY LOW PROFIL

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

K110424 · Medcomp ( Medical Components) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
289d
Days
Class 2
Risk

K110424 is an FDA 510(k) clearance for the DIGNITY MINI PORT- ATTACHABLE. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Medcomp ( Medical Components) (Harleysville, US). The FDA issued a Cleared decision on November 30, 2011 after a review of 289 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 Medcomp ( Medical Components) devices

Submission Details

510(k) Number K110424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date November 30, 2011
Days to Decision 289 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
161d slower than avg
Panel avg: 128d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 286
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