Cleared Traditional

IVY DEVICES INC. IV/MEDICAL LINE STABILIZER (K033208) - FDA 510(k) Clearance

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

K033208 · Ivy Devices, Inc. · General Hospital
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Mar 2004
Decision
168d
Days
Class 2
Risk

K033208 is an FDA 510(k) clearance for the IVY DEVICES INC. IV/MEDICAL LINE STABILIZER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Ivy Devices, Inc. (Grande Prairie, Alberta, CA). The FDA issued a Cleared decision on March 18, 2004 after a review of 168 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 Ivy Devices, Inc. devices

Submission Details

510(k) Number K033208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2003
Decision Date March 18, 2004
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 208
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