Cleared Traditional

K902109 - STATLOCK IV CONNECTOR AND ANCHOR SET

K902109 is an FDA 510(k) clearance for STATLOCK IV CONNECTOR AND ANCHOR SET, manufactured by Venetec, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K902109 · Venetec, Inc. · General Hospital
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Oct 1990
Decision
163d
Days
Class 2
Risk

K902109 is an FDA 510(k) clearance for the STATLOCK IV CONNECTOR AND ANCHOR SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Venetec, Inc. (Denver, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 163 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 Venetec, Inc. devices

FDA 510(k) Submission Details - K902109

510(k) Number K902109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1990
Decision Date October 19, 1990
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
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 824
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K902109.
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LOW VOLUME TRIFURCATED IV EXTENSION SET
K901089 · Marquette Medical, Inc. · Oct 1990
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