510(k) · Cleared
ClearedVit Kit- Freeze NX and Vit Kit- Warm NX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Irvine Scientific, Inc. · MQL Media, Reproductive
Cleared on Jun 21, 2019 as substantially equivalent to K160006 (Irvine Scientific, 2016) after a 142-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 21, 2019
- Review
- 142 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. 2 later devices descend from it, 2 citing it directly.
- 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 backK160006 Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze…Irvine Scientific · 2016 · Recalled
- This deviceK190152 Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK250445 Fast Warm - NXFujifilm Irvine Scientific · 2025
- Descendant · cites it directly · 0 of its ownK223265 CryoX Vitrification Freeze Kit / Thaw KitZhejiang Horizon Medical Technology Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView 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 | K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit… | Irvine Scientific | 2016 | 2 |
| 0 (this device) | K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | Fujifilm Irvine Scientific, Inc. | 2019 | — |
| +1 | K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | 2025 | — |
| +1 | K223265 | CryoX Vitrification Freeze Kit / Thaw Kit | Zhejiang Horizon Medical Technology Co., Ltd. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…Summary page 4…uct Code: MQL (Media, Reproductive) IV. Predicate Device: Vit Kit – Freeze, Vit Kit – Thaw K160006, Irvine Scientific The predicate device has not been subject to a design related recall. Vit Kit - Freeze NX Vit Kit… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K250445 (Fujifilm Irvine Scientific, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K160006.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MII) and pronuclear (PN)
zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified oocytes (MII) and pronuclear
(PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190152 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190152
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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