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510(k) K940406

DISPOSABLE, AMBULATORY, INFUSION PUMPS by Vlv Associates, Inc. — Product Code MEB

K940406 is an FDA 510(k) premarket notification submitted by Vlv Associates, Inc. for the device "DISPOSABLE, AMBULATORY, INFUSION PUMPS". The FDA issued a decision of ST on September 2, 1994. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Vlv Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
September 2, 1994
Date Received
January 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Vlv Associates, Inc.

  • K972957 — SA-EF MULTI-LUMEN EXTENSION SET (September 29, 1997)
  • K964876 — SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET (February 28, 1997)
  • K955783 — VLV SA.EF INFUSION PORT EXTENSION SETS (February 7, 1996)
  • K953791 — VLV SA EF INFUSION PORT (October 30, 1995)
  • K945592 — VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE (July 14, 1995)
  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K922469 — PRO-LOK EXTENSION SET(S) (March 15, 1993)
  • K904217 — PRO-LOK (TM) EXTENSION SETS (October 3, 1990)
  • K901046 — VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR (June 8, 1990)
  • K901081 — PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY (June 8, 1990)

Other clearances for product code MEB

  • K250234 — SMARTeZ™ Elastomeric Infusion Pump (RS series) (April 24, 2026)
  • K240624 — InfuLife (November 5, 2024)
  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K151650 — SMARTez elastomeric infusion pump (April 4, 2016)
  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)

FDA data resources