Cleared Traditional

K994216 - PLASTIC PORT IMPLANTABLE VENOUS ACCESS ...

K994216 is the FDA 510(k) clearance for PLASTIC PORT IMPLANTABLE VENOUS ACCESS ... by Sims Deltec, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K994216 · Sims Deltec, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2000
Decision
43d
Days
Class 2
Risk

K994216 is an FDA 510(k) clearance for the PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM. 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 January 27, 2000 after a review of 43 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 K994216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1999
Decision Date January 27, 2000
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 K994216.
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
K010426 · Sims Deltec, Inc. · Mar 2001
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
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · Sims Deltec, Inc. · Nov 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · Sims Deltec, Inc. · Oct 1999
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · Boston Scientific Corp · Oct 1998