510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K253942Substantially Equivalent

Pulmonex II Xenon System (132-503)

Mirion Technologies (Capintec), Inc., Florham Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253942 is the FDA 510(k) clearance record for Pulmonex II Xenon System (132-503), a class II device, cleared for Mirion Technologies (Capintec), Inc. on under FDA product code IYT (System, Rebreathing, Radionuclide). FDA records list 15 510(k) clearances for Mirion Technologies (Capintec), Inc., from to . As of , FDA records show no recalls naming K253942.

Clearance record

Decision date
Received
(210 days to decision)
Product code
IYT System, Rebreathing, Radionuclide
Regulation
21 CFR 892.1390
Device class
Class II
Review panel
Radiology
Applicant
Mirion Technologies (Capintec), Inc. 7 Vreeland Rd., Florham Park NJ
510(k) summary
Summary PDF
Third party review
Yes

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