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
K881465Substantially Equivalent

Cryobiological Freezer

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

K881465 is the FDA 510(k) clearance record for CRYOBIOLOGICAL FREEZER, a class I device, cleared for Cryodyne Technologies, Inc. on under FDA product code KSP (Apparatus, Cell-Freezing And Reagents). FDA records list 6 510(k) clearances for Cryodyne Technologies, Inc., from to . As of , FDA records show no recalls naming K881465.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KSP Apparatus, Cell-Freezing And Reagents
Regulation
21 CFR 864.9225
Device class
Class I
Review panel
Hematology
Applicant
Cryodyne Technologies, Inc. 400 Hoover Rd., Soquel CA
Third party review
No

Clearances, product code KSP

Trailing 12 months

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

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