Home / 510(k) Clearances / K940896

510(k) K940896

MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE by Medex, Inc. — Product Code MAV

K940896 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on August 11, 1994. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Medex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1994
Date Received
February 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Medex, Inc.

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
  • K203738 — Qitexio (March 14, 2022)
  • K042432 — PHARMGUARD TOOLBOX, MODEL G6000782 (January 4, 2005)
  • K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (April 30, 2004)
  • K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP (May 20, 2002)
  • K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP (May 9, 2000)
  • K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP (April 6, 1999)
  • K982123 — CONTRAST CONTROL DEVICE (July 21, 1998)
  • K955231 — MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP (July 18, 1996)
  • K961404 — MX960 REUSABLE PRESSURE TRANSDUCER (June 27, 1996)

Other clearances for product code MAV

  • K260035 — Digital Indeflator INFLANTE (September 4, 2026)
  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K162272 — Fluent inflation device (October 20, 2016)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)

FDA data resources