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Personal Infusor

by Science Incorporated

510(k) K971362

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 NumberK971362 Date4 Dec 1997ClearedStatusActive

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  • Withdrawn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
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 Personal Infusor is a Pump, Infusion, Elastomeric device as classified by the FDA. It is a medical device designed for the delivery of fluids through infusion.

It is supplied as a Class II device with Special Controls under product code MEB. The device received FDA 510(k) clearance (K971362) on December 4, 1997, following a traditional review process. It is manufactured by Science Incorporated in Bloomington, Minnesota, and is intended for use in general hospital settings.

Other devices from Science Incorporated

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 Personal Infusor used for?

    The Personal Infusor is a medical device designed for the delivery of fluids through infusion, specifically classified as an elastomeric infusion pump intended for use in general hospital settings.

  • How is the Personal Infusor supplied and what is its regulatory classification?

    The Personal Infusor is supplied as a Class II device with Special Controls under FDA product code MEB, and it received traditional 510(k) clearance as substantially equivalent to a legally marketed device.

  • Who manufactures the Personal Infusor and where is it made?

    The Personal Infusor is manufactured by Science Incorporated in Bloomington, Minnesota, United States, as indicated in the device’s FDA 510(k) submission details.