510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221086Substantially Equivalent

CryoRobot Select System

TMRW LIFE SCIENCES, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221086 is the FDA 510(k) clearance record for CryoRobot Select System, a class II device, cleared for Tmrw Life Sciences, Inc. on under FDA product code QUJ (Automated Cryopreservation Storage System). FDA's definition for product code QUJ reads: "To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm". FDA records list one 510(k) clearance for Tmrw Life Sciences, Inc. As of , FDA records show no recalls naming K221086.

Clearance record

Decision date
Received
(205 days to decision)
Product code
QUJ Automated Cryopreservation Storage System
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Tmrw Life Sciences, Inc. 250 Hudson St., New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QUJ

Trailing 12 months

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

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