# K221086: CryoRobot Select System

- Pathway: 510(k) (Traditional)
- Applicant: Tmrw Life Sciences, Inc.
- Decided: Nov 4, 2022 after 205 days
- Product code: QUJ (Automated Cryopreservation Storage System)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032086 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032086: Kryo Art Controlled Rate Freezer, Planer Plc (2004) Summary page 4.

## Indications for use
The CryoRobot Select System consists of the CryoRobot Select, CryoBeacons, and CryoTransporter. The indications for use for the CryoRobot Select System is shown below: The CryoRobot Select System is intended to provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm to facilitate the identification, storage, and retrieval of specimens.

Source page: https://510kreport.com/device/K221086
Methodology: https://510kreport.com/methodology