Cleared Traditional

K960431 - PRESSURE STOPCOCK/MANIFOLD

K960431 is an FDA 510(k) clearance for PRESSURE STOPCOCK/MANIFOLD, manufactured by Scientific Device Manufacturer, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K960431 · Scientific Device Manufacturer, LLC · General Hospital
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Oct 1996
Decision
272d
Days
Class 2
Risk

K960431 is an FDA 510(k) clearance for the PRESSURE STOPCOCK/MANIFOLD. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Scientific Device Manufacturer, LLC (San Rafael, US). The FDA issued a Cleared decision on October 29, 1996 after a review of 272 days - an extended review cycle.

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. 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 Scientific Device Manufacturer, LLC devices

FDA 510(k) Submission Details - K960431

510(k) Number K960431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1996
Decision Date October 29, 1996
Days to Decision 272 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
143d slower than avg
Panel avg: 129d · This submission: 272d
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 737
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K960431.
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