510(k) · Cleared
ClearedCryoRobot Select System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tmrw Life Sciences, Inc. · QUJ Automated Cryopreservation Storage System
Cleared on Nov 4, 2022 as substantially equivalent to K032086 (Planer Plc, 2004) after a 205-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Nov 4, 2022
- Review
- 205 days
- Class
- Class II
- Product code
- QUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032086 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK032086 Kryo Art Controlled Rate FreezerPlaner Plc · 2004
- This deviceK221086 CryoRobot Select SystemTmrw Life Sciences, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032086 | Kryo Art Controlled Rate Freezer | Planer Plc | 2004 | — |
| 0 (this device) | K221086 | CryoRobot Select System | Tmrw Life Sciences, Inc. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032086 | Kryo Art Controlled Rate FreezerSummary page 4…QUJ (Automated Cryopreservation Storage System) III. PREDICATE DEVICE Primary Predicate Device: Kryo ART Controlled Rate Freezer (K032086) Manufacturer: PLANER, plc. Product Code: MQG (Assisted… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QUJ devicesQUJ Automated Cryopreservation Storage System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QUJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QUJ
Too few QUJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QUJ
No recall names QUJ since 2007.
Adverse event reports per year · QUJ
No MAUDE report names QUJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221086: CryoRobot Select System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221086
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026