Cleared Traditional

K052252 - CONTRAST MEDIA TRANSFER SETS

K052252 is an FDA 510(k) clearance for CONTRAST MEDIA TRANSFER SETS, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K052252 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
90d
Days
Class 2
Risk

K052252 is an FDA 510(k) clearance for the CONTRAST MEDIA TRANSFER SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 16, 2005 after a review of 90 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.

View all B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K052252

510(k) Number K052252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2005
Decision Date November 16, 2005
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 773
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K052252.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
K052887 · Terumo Europe N.V. · Dec 2005
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5
K053129 · Nexus Medical, LLC · Dec 2005
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2
K052432 · Medtronic Minimed · Nov 2005
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS
K052722 · Hospira, Inc. · Nov 2005
SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET
K052658 · Renascence Medical, Inc. · Oct 2005
SUREFLOW SAFETY INFUSION DEVICE
K051943 · Intrasafe Medical, LLC · Oct 2005