510(k) · Cleared
ClearedCook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · MQL Media, Reproductive
Cleared on May 3, 2001 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- May 3, 2001
- Review
- 17 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK011157 Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw KitCook Urological, Inc. · 2001
- Descendant · cites it directly · 17 of its ownK093273 Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
- Descendant · 2 generations on · 14 of its ownK160006 Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze…Irvine Scientific · 2016 · Recalled
- Descendant · 3 generations on · 7 of its ownK171748 Vitrification Kit and Thawing KitKitazato Corporation · 2017
- Descendant · 3 generations on · 2 of its ownK190152 Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019
- Descendant · 4 generations on · 1 of its ownK251305 Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K093273Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010 · cites it directly17descendants
- K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…Irvine Scientific · 2016 · 2 generations on14descendants
- K171748Vitrification Kit and Thawing KitKitazato Corporation · 2017 · 3 generations on7descendants
- K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019 · 3 generations on2descendants
- K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011157 | Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit | Cook Urological, Inc. | 2001 | — |
| +1 | K093273 | Vit Kit - Freeze and Thaw | Irvine Scientific Sales Co., Inc. | 2010 | — |
| +2 | K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit… | Irvine Scientific | 2016 | 2 |
| +3 | K171748 | Vitrification Kit and Thawing Kit | Kitazato Corporation | 2017 | — |
| +3 | K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | Fujifilm Irvine Scientific, Inc. | 2019 | — |
| +4 | K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 203 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?
- Of its descendants, K093273 (Irvine Scientific Sales Co., Inc., 2010) has gone furthest, with 17 descendants of its own.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K011157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011157: Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011157
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026