Cleared Traditional

K151423 - APEX Compounding System Transfer Set

K151423 is the FDA 510(k) clearance for APEX Compounding System Transfer Set by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K151423 · B.Braun Medical, Inc. · General Hospital
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Feb 2016
Decision
267d
Days
Class 2
Risk

K151423 is an FDA 510(k) clearance for the APEX Compounding System Transfer Set. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on February 19, 2016 after a review of 267 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 K151423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2015
Decision Date February 19, 2016
Days to Decision 267 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
138d slower than avg
Panel avg: 129d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K151423.
Vial Adapter Ø20 mm
K190149 · Avenir Performance Europeenne Medical (Apem) · Oct 2019
nextaro Transfer System, nextaro va
K183187 · Sfm Medical Devices GmbH · Mar 2019
Guarded Luer Connector
K173577 · International Medical Industries, Inc. · Jun 2018
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011