510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862665Substantially Equivalent

Novacyte-U

Xsirius Medical, Inc., Rolling Hills Estates CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862665 is the FDA 510(k) clearance record for NOVACYTE-U, a class I device, cleared for Xsirius Medical, Inc. on under FDA product code KDT (Container, Specimen Mailer And Storage, Sterile). FDA records list one 510(k) clearance for Xsirius Medical, Inc. As of , FDA records show no recalls naming K862665.

Clearance record

Decision date
Received
(52 days to decision)
Product code
KDT Container, Specimen Mailer And Storage, Sterile
Regulation
21 CFR 864.3250
Device class
Class I
Review panel
Pathology
Applicant
Xsirius Medical, Inc. Peninsula Pt.e Suite 260, Rolling Hills Estates CA
Third party review
No

Clearances, product code KDT

Trailing 12 months

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

FDA records show no clearances under product code KDT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDT, 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