510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092313Substantially Equivalent

Perfusor Space Infusion Syringe Pump System

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

K092313 is the FDA 510(k) clearance record for PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM, a class II device, cleared for B.Braun Medical, Inc. on under FDA product code MEA (Pump, Infusion, Pca). FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show 4 recalls naming K092313.

Clearance record

Decision date
Received
(97 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
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 MEA

Trailing 12 months

FDA records hold no clearances under product code MEA in the trailing twelve months.

FDA records show no clearances under product code MEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MEA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260