Smartdose IV Prefilled Infusion Container

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K944351 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

ST

• PTFE Piston

  Class II

  FDA 510(k) K913285 Active Cleared 18 Dec 1991

• River Pump

  Class II

  FDA 510(k) K932895 Active Cleared 31 Mar 1994

• Smartdose III Infusion Container

  Class II

  FDA 510(k) K944352 Active Cleared 15 Nov 1995

• H/A Partial - Regular & H/a Partial - Offset

  Class II

  FDA 510(k) K913287 Active Cleared 18 Dec 1991

• Collar Button Style Venturi

  Class II

  FDA 510(k) K904594 Active Cleared 28 Jan 1991

• River Medical Microdrill System

  Class I

  FDA 510(k) K905437 Active Cleared 30 May 1991

See all devices from River Medical, Inc. →

• What is the primary function of the Smartdose IV Prefilled Infusion Container?

  This device is designed to serve as a prefilled container for holding and delivering intravenous fluids within clinical infusion systems.

• How is this device classified for regulatory purposes?

  The Smartdose IV Prefilled Infusion Container is classified as a Class 2 medical device and is subject to tracking regulations as defined by the General Hospital advisory committee.

• What is the regulatory authorization for this infusion container?

  This device is regulated under FDA 510(k) clearance K944351, which indicates it has been found substantially equivalent to legally marketed predicate devices.