Cleared Traditional

K955398 - FORMULATION PREPARATION DEVICE

K955398 is an FDA 510(k) clearance for FORMULATION PREPARATION DEVICE, 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 132-day FDA review.

K955398 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
132d
Days
Class 2
Risk

K955398 is an FDA 510(k) clearance for the FORMULATION PREPARATION DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 132 days - within the typical 510(k) review window.

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 - K955398

510(k) Number K955398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date April 04, 1996
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
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 128
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K955398.
MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE
K963583 · Medimop Medical Projects, Ltd. · Oct 1996
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · Abbott Laboratories · May 1996
CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE
K960921 · Codan Medlon, Inc. · Apr 1996
SAFELINE I.V. BAG ACCESS DEVICE
K955594 · Mcgaw, Inc. · Mar 1996
SAFELINE MULTIDOSE VIAL ADAPTER
K955595 · Mcgaw, Inc. · Mar 1996
MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
K955896 · Critical Device Corp. · Feb 1996