Medipart Drierite MP-1002
510(k) K853570
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853570 | Date7 Nov 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Medipart Jerry Alexander
Questions
AI-generated answers, 24 Sep 2026
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.