Cleared Traditional

K151423 - APEX Compounding System Transfer Set

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

K151423 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K151423

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.

LHI Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K151423.
Vial2Bag Direct Connect
K170095 · Medimop Medical Project , Ltd. · Mar 2017
OnSite-IV
K161800 · Pharmc, LLC · Dec 2016
Vented Vial Adapter Transfer Device - 13mm
K160503 · Medimop Medical Projects, Ltd. · May 2016
KIRO Set
K152441 · Kiro Robotics S.L. · Dec 2015
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
SmartSite Vented Vial Access Device
K151963 · Yukon Medical, LLC · Jul 2015
K151423 · APEX Compounding System Transfer Set
Download PDF FDA Summary B.Braun Medical, Inc.