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510(k) K092313

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM by B.Braun Medical, Inc. — Product Code MEA

K092313 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM". The FDA issued a decision of Substantially Equivalent on November 4, 2009. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2009
Date Received
July 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Pca
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by B.Braun Medical, Inc.

  • K253235 — Introcan Safety® Deep Access XL IV Catheter (May 15, 2026)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (July 31, 2024)
  • K241845 — Introcan Safety® 2 IV Catheter (July 26, 2024)
  • K241385 — Omnifix Syringe NRFit (July 13, 2024)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K223479 — AQUAbase nX (August 16, 2023)
  • K220756 — Introcan Safety 2 IV Catheter (June 23, 2022)
  • K220626 — Introcan Safety IV Catheter (May 14, 2022)
  • K213778 — IV Administration Set (March 3, 2022)

Other clearances for product code MEA

  • K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Inte (August 29, 2017)
  • K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis I (August 24, 2017)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (December 9, 2013)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR (July 15, 2005)
  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTE (December 6, 2004)
  • K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (October 18, 2004)
  • K033054 — HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (December 16, 2003)

FDA data resources