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Medipart Drierite MP-1002

by Medipart Jerry Alexander

510(k) K853570

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853570 Date7 Nov 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
IYT
Device Class
Class II
Regulation
21 CFR Part 892.1390
Advisory Committee
Radiology
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 Medipart Drierite MP-1002 is a Class II medical device classified as a System, Rebreathing, Radionuclide. It is used in radiology settings for medical procedures.

This device is manufactured by Medipart Jerry Alexander and received FDA 510(k) clearance on November 7, 1985 under K-number K853570. It is regulated under product code IYT and is not a third-party reviewed device.

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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 Medipart Drierite MP-1002 used for?

    The Medipart Drierite MP-1002 is a Class II medical device classified as a System, Rebreathing, Radionuclide. It is specifically designed for use in radiology settings during medical procedures that require rebreathing systems with radionuclide components.

  • Is the Medipart Drierite MP-1002 a single-use or reusable device?

    The device data does not specify whether the Medipart Drierite MP-1002 is single-use or reusable. This information would typically be found in the device's instructions for use or product specifications, which are not provided in the available data.

  • What regulatory approvals does the Medipart Drierite MP-1002 have?

    The Medipart Drierite MP-1002 received FDA 510(k) clearance on November 7, 1985 under K-number K853570. It is regulated under product code IYT and is classified as a Class II medical device. The device is not third-party reviewed.

  • What are the available sizes or models of the Medipart Drierite MP-1002?

    The available data does not specify different sizes or models for the Medipart Drierite MP-1002. The device appears to be marketed as a single model, MP-1002, without mention of variations in size or configuration.