510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843640Substantially Equivalent

Xenon Xe 127/Xe 133 Gas Dispenser

Mallinckrodt Critical Care, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843640 is the FDA 510(k) clearance record for XENON XE 127/XE 133 GAS DISPENSER, a class II device, cleared for Mallinckrodt Critical Care on under FDA product code IYT (System, Rebreathing, Radionuclide). FDA records list 92 510(k) clearances for Mallinckrodt Critical Care, from to . As of , FDA records show no recalls naming K843640.

Clearance record

Decision date
Received
(119 days to decision)
Product code
IYT System, Rebreathing, Radionuclide
Regulation
21 CFR 892.1390
Device class
Class II
Review panel
Radiology
Applicant
Mallinckrodt Critical Care P.O. Box 5840, St. Louis MO
Third party review
No

Clearances, product code IYT

Trailing 12 months
1 clearance under product code IYT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IYT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260