510(k) · Cleared
Recalled · Class II · 2020Medicult Vitrification Cooling/Warming, Model Ref: 1228, 1229
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origio A/S · MQL Media, Reproductive
Cleared on Aug 27, 2010 as substantially equivalent to K080446 (Vitrolife Sweden AB, 2008) after a 196-day review. Its family tree reaches back 2 generations to 2006. It has been recalled once.
- Decided
- Aug 27, 2010
- Review
- 196 days
- Class
- Class II
- Product code
- MQL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060168 (2006). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060168 | Vitrification Freeze Kit, Vitrification Thaw Kit | Irvine Scientific Sales Co., Inc. | 2006 | — |
| −1 | K080446 | Rapidvit and Rapidwarm Cleave | Vitrolife Sweden AB | 2008 | — |
| 0 (this device) | K100367 | Medicult Vitrification Cooling/Warming, Model Ref: 1228, 1229 | Origio A/S | 2010 | — |
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 MQL? 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 MQL device
- #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 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 |
|---|---|---|---|
| * | K080446 | Rapidvit and Rapidwarm CleaveSummary page 2…l characteristics of MediCult Vitrification Cooling (1228) and Warming (1229).are essentially similar to the predicate device RapidVit Tm Cleave and Rapid WarMTM Cleave (K080446), i.e. they have the same intended use and use ethylene glycol, 1,2-propanediol, and sucrose as cryoprotectants. 2010.Aug.24/BG… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 8, 2020 | Class II | Z-0100-2021 | Under Investigation by firm | There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K080446.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQL
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQL
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQL
3in 2025
MAUDE reports naming product code MQL, 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 | 3 | 212 | 0 | 0 |
| 2008 | 12 | 151 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 235 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 253 | 1 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 5 | 142 | 0 | 3 |
| 2015 | 7 | 87 | 0 | 0 |
| 2016 | 12 | 170 | 0 | 2 |
| 2017 | 10 | 113 | 0 | 0 |
| 2018 | 4 | 94 | 0 | 0 |
| 2019 | 6 | 170 | 0 | 0 |
| 2020 | 8 | 257 | 1 | 0 |
| 2021 | 1 | — | 2 | 0 |
| 2022 | 3 | 316 | 1 | 0 |
| 2023 | 5 | 199 | 1 | 1 |
| 2024 | 12 | 195 | 0 | 6 |
| 2025 | 9 | 225 | 0 | 3 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
MediCuit Vitrification Cooling Is for vitrification of human, day 3 cleavage-stage embryos.
MediCult Vitrification Warming Is for warming vitrified human, day 3 cleavage-stage embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100367: Medicult Vitrification Cooling/Warming, Model Ref: 1228, 1229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100367
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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