Cleared Traditional

K010426 - PROPORT PLASTIC VENOUS IMPLANTABLE ACCE...

K010426 is the FDA 510(k) clearance for PROPORT PLASTIC VENOUS IMPLANTABLE ACCE... by Sims Deltec, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K010426 · Sims Deltec, Inc. · General Hospital
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Mar 2001
Decision
23d
Days
Class 2
Risk

K010426 is an FDA 510(k) clearance for the PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE.... Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 8, 2001 after a review of 23 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 Sims Deltec, Inc. devices

Submission Details

510(k) Number K010426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2001
Decision Date March 08, 2001
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
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 124
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K010426.
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
K021580 · LeMaitre Vascular, Inc. · Feb 2003
VAXCEL WITH PASV PORT
K030083 · Boston Scientific Corp · Jan 2003
BARDPORT X-PORT ISP PORT
K022983 · C.R. Bard, Inc. · Sep 2002
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006 · Arrow Intl., Inc. · Oct 2000
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
K002770 · Hdc Corp. · Sep 2000
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · Sims Deltec, Inc. · Jan 2000