510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915471Substantially Equivalent

Cryobag

Janus Biomedical, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915471 is the FDA 510(k) clearance record for CRYOBAG, cleared for Janus Biomedical, Inc. on under FDA product code LPZ (Container, Frozen Donor Tissue Storage). FDA records list 2 510(k) clearances for Janus Biomedical, Inc., from to . As of , FDA records show no recalls naming K915471.

Clearance record

Decision date
Received
(817 days to decision)
Product code
LPZ Container, Frozen Donor Tissue Storage
Device class
Unclassified
Review panel
Unknown
Applicant
Janus Biomedical, Inc. 2525 Hartford Rd., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code LPZ

Trailing 12 months

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

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