Cleared Traditional

K950284 - SIMS DELTEC

K950284 is the FDA 510(k) clearance for SIMS DELTEC by Sims Deltec, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K950284 · Sims Deltec, Inc. · General Hospital
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May 1995
Decision
119d
Days
Class 2
Risk

K950284 is an FDA 510(k) clearance for the SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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. Standard predicate reliance. 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 Sims Deltec, Inc. devices

Submission Details

510(k) Number K950284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1995
Decision Date May 23, 1995
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 271
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