FDA product code QUJ: Automated Cryopreservation Storage System
QUJ is the FDA product code for automated cryopreservation storage system. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under QUJ, 1 in the last five years. The average 510(k) review took 205 days (median 205).
Definition
To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
Classification
| Field | Value |
|---|---|
| Device name | Automated Cryopreservation Storage System |
| Device class | Class II |
| Regulation | 21 CFR 884.6120 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QUJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 205 |
Compare with all 510(k) review times · Search every QUJ clearance
Top QUJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tmrw Life Sciences, Inc. | 1 | 2022-11-04 |
Most recent QUJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221086 | Tmrw Life Sciences, Inc. | CryoRobot Select System | 2022-11-04 | 205 |
Recalls for QUJ devices
openFDA lists no recalls for product code QUJ.
Frequently asked questions
What is FDA product code QUJ?
QUJ is the FDA product code for automated cryopreservation storage system. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel.
What device class is QUJ?
Class II, regulation 21 CFR 884.6120. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QUJ?
Across 1 cleared submissions the average was 205 days from receipt to decision (median 205).
Which companies have the most QUJ clearances?
Tmrw Life Sciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QUJ
- Run a recall and safety report across every QUJ manufacturer
- Watch product code QUJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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