Cleared Traditional

K043328 - MICROFLO-SAFE SCALP VEIN SET

K043328 is an FDA 510(k) clearance for MICROFLO-SAFE SCALP VEIN SET, manufactured by Dks Loversan Industria Biomedica Spa. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K043328 · Dks Loversan Industria Biomedica Spa · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
134d
Days
Class 2
Risk

K043328 is an FDA 510(k) clearance for the MICROFLO-SAFE SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Dks Loversan Industria Biomedica Spa (Appollo Beach, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 134 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K043328

510(k) Number K043328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date April 15, 2005
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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 1099
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K043328.
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K051499 · Medegen Medical Manufacturing Services · Jun 2005
MINILOC SAFETY INFUSION SET
K050600 · Specialized Health Products, Intl. · May 2005
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
K041495 · Pentaferte S.P.A · 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
F00010 - IV GRAVITY SETWITH MALE LUER SLIP
K042129 · Cedic S.R.L. · Jan 2005
K043328 · MICROFLO-SAFE SCALP VEIN SET
Download PDF FDA Summary Dks Loversan Industri…