510(k) · Cleared
Clearedcryo-GO Vitrification Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Irvine Scientific · MQK Labware, Assisted Reproduction
Cleared on Sep 26, 2024 as substantially equivalent to K200815 (Origio A/S, 2020) after a 136-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Sep 26, 2024
- Review
- 136 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K041562 (2004). No later device cites it as a predicate yet.
- Root · 5 generations backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- 4 generations backK090832 Rapid-IVitrolife Sweden AB · 2009
- 3 generations backK140207 Rapid-I KitVitrolife Sweden AB · 2014
- 2 generations backK181461 Rapid-i™ KitVitrolife Sweden AB · 2019
- 1 generation backK200815 VitriGuardOrigio A/S · 2020
- This deviceK241341 cryo-GO Vitrification DeviceFujifilm Irvine Scientific · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K041562 | Cryotip | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −4 | K090832 | Rapid-I | Vitrolife Sweden AB | 2009 | — |
| −3 | K140207 | Rapid-I Kit | Vitrolife Sweden AB | 2014 | — |
| −2 | K181461 | Rapid-i™ Kit | Vitrolife Sweden AB | 2019 | — |
| −1 | K200815 | VitriGuard | Origio A/S | 2020 | — |
| 0 (this device) | K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 2024 | — |
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 MQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQK device
- #1 K241626 SperSort™ Sperm Sorting Chip (IPG02)score 10.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K200815 | VitriGuardSummary page 5…egulatory Class: Class II Product Code: MQK (Labware, Assisted Reproduction) Legally Marketed Predicate Device: VitriGuard (K200815) ORIGIO A/S /CooperSurgical, Inc. 95 Corporate Drive, T… | 2020 |
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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K200815.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MQK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQK
259in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQK
1in 2025
MAUDE reports naming product code MQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 454 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 6 | 270 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 4 | 154 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 4 | 163 | 0 | 0 |
| 2025 | 3 | 259 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241341: cryo-GO Vitrification Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241341
Report an extraction error
Are you the manufacturer?
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