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MiniMed III Infusion Pump

by Medtronic Minimed

510(k) K895436

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895436 Date24 May 1990ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Modified Minimed III Infusion Pump
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 MiniMed III Infusion Pump is a Class II infusion pump designed for the continuous delivery of insulin. It is intended for subcutaneous administration in patients requiring insulin therapy for diabetes management, providing precise and programmable insulin infusion rates to help maintain glycemic control.

This device is supplied as a reusable, non-sterile medical device and is intended for use in hospital and outpatient settings. It operates on battery power and requires periodic calibration and maintenance. The pump is regulated under FDA 510(k) clearance (K895436) and falls under the regulatory category of 880.5725, with no third-party involvement. Multiple model and reference codes are associated with its regulatory submissions, though these do not affect its core functionality or usage.

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