510(k) · Cleared
ClearedVitriblast, Thermoblast, Model VB-010, TB-010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidacon International AB · MQL Media, Reproductive
Cleared on Jun 15, 2010 as substantially equivalent to K060168 (Irvine Scientific Sales Co., Inc., 2006) and 1 other predicate after a 336-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jun 15, 2010
- Review
- 336 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 2
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
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? (2)
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 |
|---|---|---|---|
| * | K060168 | Vitrification Freeze Kit, Vitrification Thaw KitSummary page 2…welling during thawing and the removal of the ethylene glycol. Products claimed for substantial equivalence: * VitKit-Freeze and VitKit-Thaw from Irvine Scientific (K060 168) (DMSO, Ethylene glycol, Sucrose) * Vitri Freeze Kit from FertiPro (K070 135) (same as above + Ficoll) Comparison to predicat… | 2006 |
| * | K070135 | Vitrifreeze Medium; Vitrithaw MediumSummary page 2…d for substantial equivalence: * VitKit-Freeze and VitKit-Thaw from Irvine Scientific (K060 168) (DMSO, Ethylene glycol, Sucrose) * Vitri Freeze Kit from FertiPro (K070 135) (same as above + Ficoll) Comparison to predicate device The two predicate devices were compared in the following areas and were… | 2007 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K060168.
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?
VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast Thaw Kit for optimal recovery of specimens.
This product is used for Assisted Reproductive Technology (ART.) procedures.
ThermoBlast is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing using Nidacon's VitriBlast Kit. It is designed for optimal recovery of specimens.
This product is used for Assisted Reproductive Technology (A.R.T.) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092107: Vitriblast, Thermoblast, Model VB-010, TB-010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092107
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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