510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881466Substantially Equivalent

Cell-Culture Shaker

Cryodyne Technologies, Inc., Soquel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881466 is the FDA 510(k) clearance record for CELL-CULTURE SHAKER, a class I device, cleared for Cryodyne Technologies, Inc. on under FDA product code KJB (Apparatus, Roller). FDA records list 6 510(k) clearances for Cryodyne Technologies, Inc., from to . As of , FDA records show no recalls naming K881466.

Clearance record

Decision date
Received
(12 days to decision)
Product code
KJB Apparatus, Roller
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
Cryodyne Technologies, Inc. 400 Hoover Rd., Soquel CA
Third party review
No

Clearances, product code KJB

Trailing 12 months

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

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