Cleared Traditional

SAFECONNECT VALVE (CATALOG NO. XXXX) (K955775) - FDA 510(k) Clearance

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

K955775 · Faulding Medical Device Co. · General Hospital
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Nov 1996
Decision
330d
Days
Class 2
Risk

K955775 is an FDA 510(k) clearance for the SAFECONNECT VALVE (CATALOG NO. XXXX). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Faulding Medical Device Co. (Scottsdale, US). The FDA issued a Cleared decision on November 15, 1996 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Faulding Medical Device Co. devices

Submission Details

510(k) Number K955775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date November 15, 1996
Days to Decision 330 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 129d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K955775.
GORE IRRIGATION SET
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INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438 · Baxter Healthcare Corp · Apr 1997
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K964850 · Baxter Healthcare Corp · Feb 1997
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893 · Baxter Healthcare Corp · Oct 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · Merit Medical Systems, Inc. · Aug 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
K961495 · Baxter Healthcare Corp · Jun 1996