510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090905Substantially Equivalent

Addease 20Mm Binary Connector with 17 Ga. Needle

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

K090905 is the FDA 510(k) clearance record for ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE, 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 4 recalls naming K090905.

Clearance record

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