Cleared Traditional

K955775 - SAFECONNECT VALVE (CATALOG NO. XXXX)

K955775 is an FDA 510(k) clearance for SAFECONNECT VALVE (CATALOG NO. XXXX), manufactured by Faulding Medical Device Co.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 330-day FDA review.

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

FDA 510(k) Submission Details - K955775

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.

FPA Device Classification - Class 2, Special Controls

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 645
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K955775.
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
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POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456 · Medtronic Minimed · Jan 1997
MODEL D-290P ADMINISTRATION SET
K964384 · Patient Solutions, Inc. · Jan 1997
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893 · Baxter Healthcare Corp · Oct 1996
DELTEC SUBCUTANEOUS INFUSION SET
K963009 · Sims Deltec, Inc. · Oct 1996
SAFE MATE I.V. EXTENSION SETS
K962801 · Biological & Environmental Control Laboratories · Aug 1996