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ABC Syringe Infusion Pump Model 4100

by Elixir Corporation

510(k) K072603

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 NumberK072603 Date23 Oct 2008ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
FRN
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 ABC Syringe Infusion Pump Model 4100 is a Class II infusion pump designed for controlled delivery of fluids via syringe. It is intended for precise volumetric infusion, commonly used in clinical settings such as anesthesia and operating rooms to administer medications or fluids at programmable rates. Its syringe-driven mechanism ensures accurate dosing, making it suitable for critical applications requiring high reliability and precision.

This device is supplied as a reusable medical instrument, intended for use in hospital environments. It features an all-metal housing for durability and EMI resistance, facilitating easy cleaning and maintenance. The pump operates in sterile or semi-sterile conditions, depending on clinical protocols, and is regulated under FDA 510(k) clearance (K072603). Regular calibration and maintenance, including yearly testing, are recommended to ensure proper function and safety.

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 ABC Syringe Infusion Pump Model 4100 used for?

    The ABC Syringe Infusion Pump Model 4100 is designed for precise volumetric infusion of fluids, commonly used in clinical settings such as anesthesia and operating rooms. Its syringe-driven mechanism ensures accurate dosing, making it ideal for administering medications or fluids at programmable rates in critical applications where reliability and precision are essential.

  • Is the ABC Syringe Infusion Pump Model 4100 reusable or single-use?

    The ABC Syringe Infusion Pump Model 4100 is supplied as a reusable medical instrument. This design allows for easy cleaning and maintenance, which is particularly beneficial in hospital environments where durability and repeated use are required. Regular calibration and maintenance, including yearly testing, are recommended to ensure proper function and safety.

  • What materials is the housing of the ABC Syringe Infusion Pump Model 4100 made from?

    The pump features an all-metal housing, which provides durability and resistance to electromagnetic interference (EMI). This construction facilitates easy cleaning and maintenance, ensuring long-term reliability in clinical settings.

  • Can the ABC Syringe Infusion Pump Model 4100 be used in sterile or semi-sterile conditions?

    The ABC Syringe Infusion Pump Model 4100 is intended for use in sterile or semi-sterile conditions, depending on the clinical protocols in place. Its reusable nature and robust design make it suitable for environments where maintaining sterility is critical, such as operating rooms and anesthesia settings.

  • What maintenance is required for the ABC Syringe Infusion Pump Model 4100?

    Regular maintenance is essential to ensure the proper function and safety of the ABC Syringe Infusion Pump Model 4100. This includes yearly testing and routine calibration. The all-metal housing and durable design facilitate easy cleaning, but adherence to manufacturer guidelines for maintenance is strongly recommended to sustain performance and reliability.