510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854719Substantially Equivalent

Lung Care (Specimen Transport & Storage Container)

Xsirius Scientific, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854719 is the FDA 510(k) clearance record for LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER), a class I device, cleared for Xsirius Scientific, Inc. on under FDA product code LIO (Device, Specimen Collection). FDA records list one 510(k) clearance for Xsirius Scientific, Inc. As of , FDA records show no recalls naming K854719.

Clearance record

Decision date
Received
(94 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Xsirius Scientific, Inc. Tobias Klinger, Los Angeles CA
Third party review
No

Clearances, product code LIO

Trailing 12 months

FDA records hold no clearances under product code LIO in the trailing twelve months.

FDA records show no clearances under product code LIO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260