Cleared Traditional

PHARMACIA DELTEC WINGED INFUSION SET (K923019) - FDA 510(k) Clearance

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

K923019 · Pharmacia Deltec, Inc. · General Hospital
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Apr 1993
Decision
302d
Days
Class 2
Risk

K923019 is an FDA 510(k) clearance for the PHARMACIA DELTEC WINGED INFUSION SET. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 21, 1993 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pharmacia Deltec, Inc. devices

Submission Details

510(k) Number K923019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date April 21, 1993
Days to Decision 302 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
173d slower than avg
Panel avg: 129d · This submission: 302d
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 42
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K923019.
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AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
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MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · Medtronic Vascular · Nov 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987