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510(k) K253942

Pulmonex II Xenon System (132-503) by Mirion Technologies (Capintec), Inc. — Product Code IYT

K253942 is an FDA 510(k) premarket notification submitted by Mirion Technologies (Capintec), Inc. for the device "Pulmonex II Xenon System (132-503)". The FDA issued a decision of Substantially Equivalent on July 7, 2026. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2026
Date Received
December 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Rebreathing, Radionuclide
Device Class
Class II
Regulation Number
892.1390
Review Panel
RA
Submission Type

Other clearances for product code IYT

  • K200916 — Patient Administration Set (September 1, 2020)
  • K953513 — XENON CIRCUIT (November 3, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K914747 — XENON CIRCUIT (February 27, 1992)
  • K913416 — TETLEY PATIENT ADMINISTRATION SET (October 28, 1991)
  • K912626 — BOLUS XENON CIRCUIT (August 2, 1991)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (October 3, 1990)
  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)

FDA data resources