Pulmonex II Xenon System (132-503)
FDA 510(k) K253942 · Mirion Technologies (Capintec), Inc.
510(k) numberK253942
Submission
- Device name
- Pulmonex II Xenon System (132-503)
- Applicant
- Mirion Technologies (Capintec), Inc.
Florham Park, NJ, US - Received
- December 9, 2025
- Decision date
- July 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code IYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200916 | Patient Administration SetIYT · Traditional | Cyclomedica Australia Pty, Ltd. | 09/01/2020SE |
| K953513 | Xenon CircuitIYT · Traditional | King Systems Corp. | 11/03/1995SE |
| K952223 | Xenon Gas Breathing CircuitIYT · Traditional | Intertech Resources, Inc. | 08/11/1995SE |
| K914747 | Xenon CircuitIYT · Traditional | Gibeck, Inc. | 02/27/1992SE |
| K913416 | Tetley Patient Administration SetIYT · Traditional | Tetley Medical , Ltd. | 10/28/1991SE |
| K912626 | Bolus Xenon CircuitIYT · Traditional | Vital Signs, Inc. | 08/02/1991SE |
| K904684 | Amici Krypton Administration System, ModificationIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903805 | Amici Xenon Administration SetIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903694 | Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional | Amici, Inc. | 10/03/1990SE |
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | Medipart Jerry Alexander | 02/26/1990SE |
Questions and answers
When was Pulmonex II Xenon System (132-503) cleared by the FDA?
Pulmonex II Xenon System (132-503) (K253942) received a 510(k) decision of Substantially Equivalent on July 7, 2026, 210 days after the submission was received.
What is the product code of K253942?
The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.