510(k) · Cleared
ClearedVitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Vitavitro Bio-Tech Co., Ltd. · MQL Media, Reproductive
Cleared on Aug 29, 2018 as substantially equivalent to K160864 (Kitazato Biopharma Co., Ltd., 2016) after a 232-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Aug 29, 2018
- Review
- 232 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000309 (2000). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK000309 Blastocyst Freeze Medium, Blastocyst Thaw MediumIrvine Scientific Sales Co., Inc. · 2000
- 4 generations backK032154 G-Freezekit BlastVitrolife AB · 2004
- 3 generations backK073522 Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 2008
- 2 generations backK093273 Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
- 1 generation backK160864 Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. · 2016
- This deviceK180073 Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro…Shenzhen Vitavitro Bio-Tech Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000309 | Blastocyst Freeze Medium, Blastocyst Thaw Medium | Irvine Scientific Sales Co., Inc. | 2000 | — |
| −4 | K032154 | G-Freezekit Blast | Vitrolife AB | 2004 | — |
| −3 | K073522 | Vitrification Kit & Vitrification Warming Kit | Sage In-Vitro Fertilization, Inc. | 2008 | — |
| −2 | K093273 | Vit Kit - Freeze and Thaw | Irvine Scientific Sales Co., Inc. | 2010 | — |
| −1 | K160864 | Cryotop Vitrification Kit and Cryotop Thawing Kit | Kitazato Biopharma Co., Ltd. | 2016 | — |
| 0 (this device) | K180073 | Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set | Shenzhen Vitavitro Bio-Tech Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
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 |
|---|---|---|---|
| * | K160864 | Cryotop Vitrification Kit and Cryotop Thawing KitSummary page 4…lass II 3. Legally Marketed Predicate Device Trade Name Cryotop® Vitrification Kit and Cryotop® Thawing Kit 510(k) Number K160864 Manufacturer KITAZATO BioPharma Co., Ltd. The predicate device has not been subject to a design-related recall.… | 2016 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.
VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.
VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180073: Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180073
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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