510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955398Substantially Equivalent

Formulation Preparation Device

B.Braun Medical, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955398 is the FDA 510(k) clearance record for FORMULATION PREPARATION DEVICE, a class II device, cleared for B.Braun Medical, Inc. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show no recalls naming K955398.

Clearance record

Decision date
Received
(132 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
B.Braun Medical, Inc. 824 Twelfth Ave., Bethlehem PA
510(k) summary
Summary
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to November 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260
November 20260