Cleared Traditional

K202618 - IV Administration Sets

K202618 is an FDA 510(k) clearance for IV Administration 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 379-day FDA review.

K202618 · B.Braun Medical, Inc. · General Hospital
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Sep 2021
Decision
379d
Days
Class 2
Risk

K202618 is an FDA 510(k) clearance for the IV Administration 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 September 24, 2021 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K202618

510(k) Number K202618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2020
Decision Date September 24, 2021
Days to Decision 379 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
250d slower than avg
Panel avg: 129d · This submission: 379d
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 769
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K202618.
Microvolume Luer Access Device
K212842 · B.Braun Medical, Inc. · Jan 2022
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
K213089 · Ivenix, Inc. · Nov 2021
Intravascular Administration Sets
K203609 · Baxter Healthcare Corporation · Sep 2021
I.V. Administration Set
K210381 · Bq Plus Medical Co., Ltd. · Aug 2021
Insignis Subcutaneous Needle Sets
K202279 · Innovative Health Sciences, LLC · Aug 2021
Firefly Needleless Connector
K203796 · Puracath Medical, Inc. · Jul 2021