510(k) · Cleared
ClearedVit Kit - Freeze and Thaw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Scientific Sales Co., Inc. · MQL Media, Reproductive
Cleared on Mar 3, 2010 as substantially equivalent to K080446 (Vitrolife Sweden AB, 2008) and 3 other predicates after a 135-day review. Its family tree reaches back 3 generations to 2000. 17 later devices descend from it.
- Decided
- Mar 3, 2010
- Review
- 135 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K000309 (2000). 7 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000309 Blastocyst Freeze Medium, Blastocyst Thaw MediumIrvine Scientific Sales Co., Inc. · 2000
- 2 generations backK032154 G-Freezekit BlastVitrolife AB · 2004
- 1 generation backK073522 Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 2008
- This deviceK093273 Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
- Descendant · cites it directly · 14 of its ownK160006 Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze…Irvine Scientific · 2016 · Recalled
- Descendant · 2 generations on · 7 of its ownK171748 Vitrification Kit and Thawing KitKitazato Corporation · 2017
- Descendant · 2 generations on · 2 of its ownK190152 Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK251305 Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025
- Descendant · 2 generations on · 1 of its ownK173731 SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification…CooperSurgical, Inc. · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…Irvine Scientific · 2016 · cites it directly14descendants
- K171748Vitrification Kit and Thawing KitKitazato Corporation · 2017 · 2 generations on7descendants
- K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019 · 2 generations on2descendants
- K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025 · 3 generations on1descendant
- K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit…CooperSurgical, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000309 | Blastocyst Freeze Medium, Blastocyst Thaw Medium | Irvine Scientific Sales Co., Inc. | 2000 | — |
| −2 | K032154 | G-Freezekit Blast | Vitrolife AB | 2004 | — |
| −1 | K073522 | Vitrification Kit & Vitrification Warming Kit | Sage In-Vitro Fertilization, Inc. | 2008 | — |
| 0 (this device) | 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 |
| +2 | K171748 | Vitrification Kit and Thawing Kit | Kitazato Corporation | 2017 | — |
| +2 | K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | Fujifilm Irvine Scientific, Inc. | 2019 | — |
| +3 | K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | 2025 | — |
| +2 | K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming… | CooperSurgical, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (4)
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 1…thawing and recovery media Classification Name: Reproductive Media (21 CFR § 884.6180) Predicate Device: RapidVit TM Cleave (K080446) RapidWarM TM Warm (K080446) Vit Kit®- Freeze (K060168)… | 2008 |
| * | K060168 | Vitrification Freeze Kit, Vitrification Thaw KitSummary page 1…884.6180) Predicate Device: RapidVit TM Cleave (K080446) RapidWarM TM Warm (K080446) Vit Kit®- Freeze (K060168) Vit Kit® - Thaw (K060168) Vitrification Kit (K0… | 2006 |
| * | K073522 | Vitrification Kit & Vitrification Warming KitSummary page 2…Vit Kit®- Freeze (K060168) Vit Kit® - Thaw (K060168) Vitrification Kit (K073522) Vitrification Warming Kit (K073522) Cook IVF Freeze/Th… | 2008 |
| * | K011157 | Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw KitSummary page 5…ed in April 2006 with the intended use in the assisted reproductive procedure of vitrification and thawing blastocysts. The predicate device, Cook IVF Freeze/Thaw Kits (K01 1157) were cleared in May 2001 with the intended for use in the cryopreservation, slow freezing, of zygotes or embryos and thawing of… | 2001 |
What descends from it? (17)
See all 172 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 10 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K160006 (Irvine Scientific, 2016) has gone furthest, with 14 descendants of its own.
- 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?
Vit Kit® Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) is intended for use in the vitrification of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage Embryos) is intended for use in the thawing of vitrified 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/K093273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093273: Vit Kit - Freeze and Thaw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093273
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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