510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K100640Substantially Equivalent

20 Mmvial Fluid Transfer Adapter, Model 7E2500

B.Braun Medical, Inc., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100640 is the FDA 510(k) clearance record for 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500, 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 K100640.

Clearance record

Decision date
Received
(139 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. 901 Marcon Blvd., Allentown PA
510(k) summary
Summary PDF
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