Disp. Radioaerosol Kit (Mp-400) to Fit Lead Shield

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K896475 ↗

FDA Product Code

IYT

Device Class

Class II

Regulation

21 CFR Part 892.1390

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Medipart Corrugated Polyethylene & E.V.A. Tubing

  Class I

  FDA 510(k) K853569 Active Cleared 7 Nov 1985

• Medipart Soda Lime Mp-3522

  Class I

  FDA 510(k) K853571 Active Cleared 29 Oct 1985

• Medipart Xenon Breathing Kit Mp-Oixm-I

  Class II

  FDA 510(k) K850366 Active Cleared 30 Apr 1985

• Mp-Xmv Disposable Face Mask

  Class I

  FDA 510(k) K862783 Active Cleared 1 Aug 1986

• Medipart Radioaerosol Delivery Sys for Ultravent S

  Class I

  FDA 510(k) K854551 Active Cleared 19 Dec 1985

• Medipart Xenon Breathing Kit Mp-02XM-I

  Class II

  FDA 510(k) K850367 Active Cleared 30 Apr 1985

See all devices from Medipart Jerry Alexander →

• What is the primary function of the MP-400 Radioaerosol Kit?

  The MP-400 is a radionuclide rebreathing system specifically designed for use in radiology applications. It serves as a component for the administration of radioaerosols during diagnostic imaging procedures.

• Is the MP-400 kit intended for single use?

  Yes, the device is identified as a disposable radioaerosol kit. This design ensures that the system is used for a single procedure to maintain hygiene and prevent cross-contamination during diagnostic imaging.

• What is the regulatory status of this device?

  The MP-400 Radioaerosol Kit has received FDA 510(k) clearance. It is classified under regulation number 892.1390 and is categorized under product code IYT within the radiology medical specialty.