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3100 Infusion Pump

by Graseby Medical, Ltd.

510(k) K912192

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 NumberK912192 Date14 Feb 1992ClearedStatusActive

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  • Withdrawn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
FDA applicant
Graseby Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 device is an infusion pump, specifically a pump for infusion, as defined in the device name and specifications. It is a medical device used for delivering fluids, such as medications or nutrients, into a patient's body in controlled amounts.

It is supplied as a reusable device, intended for use in general hospital settings. The device received FDA 510(k) clearance (K912192) on February 14, 1992, and is classified as a Class II device under regulation number 880.5725. It is manufactured by Graseby Medical Ltd. and identified by product code FRN.

Other devices from Graseby Medical, Ltd.

Questions

AI-generated answers, 21 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 3100 Infusion Pump used for?

    The 3100 Infusion Pump is used for delivering fluids such as medications or nutrients into a patient's body in controlled amounts, as it is designed for infusion therapy in general hospital settings.

  • Is the 3100 Infusion Pump reusable or single-use?

    The 3100 Infusion Pump is supplied as a reusable device, meaning it is intended for multiple uses after proper cleaning and maintenance, not for single-use disposal.

  • How was the 3100 Infusion Pump cleared for market?

    The device received FDA 510(k) clearance under submission K912192 on February 14, 1992, based on a determination of substantial equivalence to a legally marketed predicate device.

  • What regulatory classification does the 3100 Infusion Pump have?

    The 3100 Infusion Pump is classified as a Class II medical device under regulation number 880.5725, which governs infusion pumps in the United States.

  • Who manufactures the 3100 Infusion Pump and where is it located?

    The 3100 Infusion Pump is manufactured by Graseby Medical Ltd., located at Colonial Way, Watford, Herts., WD24 4LG, United Kingdom.