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MedFlo Elastomeric Pump

by Mps Acacia

510(k) K052451

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052451 Date8 Dec 2005ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Mps Acacia Medflo Elastomeric Pump
510(k) Number
FDA Product Code
MEB
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MedFlo Elastomeric Pump is a Class II infusion device designed for elastomeric delivery of fluids. It is classified as an elastomeric pump, intended for continuous or intermittent administration of medications, including local anesthetics or narcotics, in clinical settings such as general hospitals. Its elastomeric construction enables sustained fluid flow without external power sources, making it suitable for prolonged therapeutic applications.

This device is supplied as a single-use, non-sterile elastomeric pump and is regulated under FDA 510(k) clearance (K052451) with a decision date of December 8, 2005. It falls under product code MEB and regulation 880.5725, intended for general hospital use. No MRI safety information or reusable specifications are provided in the data. Storage and handling instructions are not detailed beyond standard medical device protocols.

Other devices from Mps Acacia

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MedFlo Elastomeric Pump used for?

    The MedFlo Elastomeric Pump is designed for the continuous or intermittent administration of medications, such as local anesthetics or narcotics, in clinical settings like general hospitals. Its elastomeric construction allows sustained fluid flow without requiring external power sources, making it suitable for prolonged therapeutic applications.

  • Is the MedFlo Elastomeric Pump single-use or reusable?

    The MedFlo Elastomeric Pump is supplied as a single-use device. This means it is intended for one-time use only and should not be reused after deployment, adhering to standard medical device safety protocols.

  • What is the sterility status of the MedFlo Elastomeric Pump?

    The MedFlo Elastomeric Pump is supplied in a non-sterile state. For clinical use, it should be handled in accordance with standard medical device preparation protocols to ensure proper sterility before administration.

  • How is the MedFlo Elastomeric Pump regulated?

    The MedFlo Elastomeric Pump is regulated under FDA 510(k) clearance with the clearance number K052451, granted on December 8, 2005. It falls under product code MEB and regulation 880.5725, intended for general hospital use.

  • Are there specific storage instructions for the MedFlo Elastomeric Pump?

    The provided data does not specify detailed storage instructions beyond standard medical device protocols. It is recommended to follow general guidelines for handling and storing medical devices to maintain their integrity and functionality until use.