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I.V. Roller Guard Clamp

by Plastic Manufacturing and Marketing Group, Inc.

510(k) K942446

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 NumberK942446 Date17 Feb 1995ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Iv Roller Guard Clamp is a device that acts as a flow regulator for infusion sets, adjusting the flow rate of medication by moving the rollers. It is used in medical settings to control the flow of fluids during infusion or transfusion. The device is designed to provide simple and stable flow rate adjustment. It is a type of clamp used in iv infusion sets.

The Iv Roller Guard Clamp is supplied as a single-use device and is made from medical-grade materials such as ABS/PP and PE. It is manufactured according to ISO 8536-4 standards, meeting international safety and performance requirements. The device has FDA 510K clearance, indicated by the k number K942446. It is available in various settings, including general hospitals.

Questions

AI-generated answers, 24 Sep 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 I.V. Roller Guard Clamp used for?

    The I.V. Roller Guard Clamp is used to control the flow of fluids during infusion or transfusion, providing simple and stable flow rate adjustment.

  • Is the I.V. Roller Guard Clamp reusable?

    No, the I.V. Roller Guard Clamp is supplied as a single-use device, reducing the risk of infection and ensuring patient safety.

  • What materials is the I.V. Roller Guard Clamp made from?

    The I.V. Roller Guard Clamp is made from medical-grade materials such as ABS/PP and PE, meeting international safety and performance requirements.

  • What standards does the I.V. Roller Guard Clamp meet?

    The I.V. Roller Guard Clamp meets ISO 8536-4 standards, ensuring compliance with international safety and performance requirements.