Cleared Traditional

K173361 - IV Administration Set

K173361 is an FDA 510(k) clearance for IV Administration Set, 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 243-day FDA review.

K173361 · B.Braun Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2018
Decision
243d
Days
Class 2
Risk

K173361 is an FDA 510(k) clearance for the IV Administration Set. 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 June 26, 2018 after a review of 243 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

FDA 510(k) Submission Details - K173361

510(k) Number K173361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2017
Decision Date June 26, 2018
Days to Decision 243 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
114d slower than avg
Panel avg: 129d · This submission: 243d
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 558
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K173361.
Tamper Evident Cap with Male Luer Lock
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K173665 · Amsino International, Inc. · Sep 2018
MiniMed Mio Advance infusion set
K173879 · Unomedical A/S · Mar 2018
IV Administration Sets
K170595 · B.Braun Medical, Inc. · Nov 2017
IV Fat Emulsion Administration Sets
K172544 · Baxter Healthcare Corporation · Sep 2017