Cleared Traditional

K221086 - CryoRobot Select System (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221086 · Tmrw Life Sciences, Inc. · Obstetrics & Gynecology device
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Nov 2022
Decision
205d
Days
Class 2
Risk

K221086 is an FDA 510(k) clearance for the CryoRobot Select System. Classified as Automated Cryopreservation Storage System (product code QUJ), Class II - Special Controls.

Submitted by Tmrw Life Sciences, Inc. (New York, US). The FDA issued a Cleared decision on November 4, 2022 after a review of 205 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tmrw Life Sciences, Inc. devices

Submission Details

510(k) Number K221086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2022
Decision Date November 04, 2022
Days to Decision 205 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 160d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QUJ Automated Cryopreservation Storage System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
Definition To Provide An Automated Liquid Nitrogen Storage System For Oocytes, Embryos, And Sperm.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.