Cleared Traditional

SIMS SILO NEEDLE DE-ACCESS ENCLOSURE (K935767) - FDA 510(k) Clearance

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

K935767 · Sims Deltec, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
713d
Days
Class 2
Risk

K935767 is an FDA 510(k) clearance for the SIMS SILO NEEDLE DE-ACCESS ENCLOSURE. 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 November 15, 1995 after a review of 713 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Sims Deltec, Inc. devices

Submission Details

510(k) Number K935767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date November 15, 1995
Days to Decision 713 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
584d slower than avg
Panel avg: 129d · This submission: 713d
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 43
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K935767.
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AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
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Q-PORT SYSTEM KIT
K894650 · Quinton, Inc. · Mar 1990
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K873735 · Medtronic Vascular · Nov 1987