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510(k) K940117

MID-500 by Block Medical, Inc. — Product Code MEB

K940117 is an FDA 510(k) premarket notification submitted by Block Medical, Inc. for the device "MID-500". The FDA issued a decision of ST on June 10, 1994. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Block Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
June 10, 1994
Date Received
January 10, 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 Block Medical, Inc.

  • K944692 — C-SERIES HOMEPUMP (May 2, 1995)
  • K934551 — VERIFUSE AMBULATORY PUMP (March 17, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K932740 — HOMEPUMP NSF (October 6, 1993)
  • K904663 — AUTO SASH (TM) (November 23, 1992)
  • K914924 — CHEMO PRIMING PIN(TM) (March 6, 1992)
  • K914855 — MULTIPLE DOSE CONTROLLER (January 24, 1992)
  • K914854 — THUMPER (January 24, 1992)
  • K910695 — AUTO SASH (TM) (March 21, 1991)
  • K902891 — VERIFUSE AMBULATORY PUMP (November 21, 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