Cleared Traditional

K962751 - IDEAS' DUAL PORT

K962751 is the FDA 510(k) clearance for IDEAS' DUAL PORT by Ideas For Medicine, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K962751 · Ideas For Medicine, Inc. · General Hospital
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Sep 1996
Decision
77d
Days
Class 2
Risk

K962751 is an FDA 510(k) clearance for the IDEAS' DUAL PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Ideas For Medicine, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 30, 1996 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ideas For Medicine, Inc. devices

Submission Details

510(k) Number K962751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date September 30, 1996
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 110
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K962751.
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066 · C.R. Bard, Inc. · Mar 1997
CELSITE PORT WITH PRECONNECTED CATHETER
K962230 · B.Braun Medical, Inc. · Dec 1996
A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
K963684 · Arrow Intl., Inc. · Oct 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
K961615 · Arrow Intl., Inc. · Jul 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652 · Arrow Intl., Inc. · Jul 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
K961583 · Arrow Intl., Inc. · Jul 1996