Cleared Traditional

K143082 - IV Administration Sets with 200(micro)m...

K143082 is the FDA 510(k) clearance for IV Administration Sets with 200(micro)m... by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K143082 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
270d
Days
Class 2
Risk

K143082 is an FDA 510(k) clearance for the IV Administration Sets with 200(micro)m Blood Filter. 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 July 24, 2015 after a review of 270 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 B.Braun Medical, Inc. devices

Submission Details

510(k) Number K143082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2014
Decision Date July 24, 2015
Days to Decision 270 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
141d slower than avg
Panel avg: 129d · This submission: 270d
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 278
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K143082.
BD FlowSmart Set, MiniMed Pro-Set
K160651 · Becton, Dickinson and Company · Apr 2016
Extension Set
K153293 · B.Braun Medical, Inc. · Apr 2016
BD FlowSmart Set, MiniMed Pro-Set
K153257 · Becton, Dickinson and Company · Dec 2015
IV ADMINISTRATION SET WITH HAND PUMP
K140838 · B.Braun Medical, Inc. · Dec 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · B.Braun Medical, Inc. · Aug 2014
CARESITE LUER ACCESS DEVICE
K140311 · B.Braun Medical, Inc. · May 2014