Cleared Traditional

K042129 - F00010 - IV GRAVITY SETWITH MALE LUER SLIP (FDA 510(k) Clearance)

Also includes:
F00027 - IV GRAVITY SET WITH MALE LUER LOCK

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

K042129 · Cedic S.R.L. · General Hospital
Jan 2005
Decision
174d
Days
Class 2
Risk

K042129 is an FDA 510(k) clearance for the F00010 - IV GRAVITY SETWITH MALE LUER SLIP. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on January 27, 2005 after a review of 174 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.

Submission Details

510(k) Number K042129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2004
Decision Date January 27, 2005
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 169d · This submission: 174d
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 29
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