Cleared Traditional

K042129 - F00010 - IV GRAVITY SETWITH MALE LUER SLIP

Also marketed or referenced as:
F00027 - IV GRAVITY SET WITH MALE LUER LOCK

K042129 is an FDA 510(k) clearance for F00010 - IV GRAVITY SETWITH MALE LUER SLIP, manufactured by Cedic S.R.L.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K042129 · Cedic S.R.L. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Cedic S.R.L. devices

FDA 510(k) Submission Details - K042129

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
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 770
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K042129.
MICROFLO-SAFE SCALP VEIN SET
K043328 · Dks Loversan Industria Biomedica Spa · Apr 2005
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
K050207 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2005
DRAGON HEART I.V. SET
K043235 · Dragon Heart Medical Devices Co., Ltd. · Mar 2005
LUTH-ALL SUB-Q NEEDLE SET
K042666 · Luth-All Medical Products, LLC · Dec 2004
NEXUS INTRAVENOUS TUBING SETS (NIVTS)
K041861 · Nexus Medical, LLC · Nov 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936 · Baxter Healthcare Corp · Nov 2004