510(k) · Cleared
ClearedCook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ob/Gyn · MQL Media, Reproductive
Cleared on Sep 13, 2000 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 13, 2000
- Review
- 40 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK002383 Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm…Cook Ob/Gyn · 2000
- Descendant · cites it directly · 4 of its ownK152782 Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf…William A. Cook Australia Pty., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK190199 SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation · 2019
- Descendant · 3 generations on · 1 of its ownK212410 VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumShenzhen Vitavitro Biotech Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK241095 ARTSMedia Semen Wash MediumArtsmedia Denmark Aps · 2024
- Descendant · 3 generations on · 0 of its ownK192644 GM501 SpermAir and GM501 SpermActiveHamilton Thorne Incorporated · 2020
Most influential descendants
Showing 5 of 5 · See all- K152782Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf SpermientWilliam A. Cook Australia Pty., Ltd. · 2015 · cites it directly4descendants
- K190199SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation · 2019 · 2 generations on3descendants
- K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumShenzhen Vitavitro Biotech Co., Ltd. · 2022 · 3 generations on1descendant
- K241095ARTSMedia Semen Wash MediumArtsmedia Denmark Aps · 2024 · 4 generations on0descendants
- K192644GM501 SpermAir and GM501 SpermActiveHamilton Thorne Incorporated · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit | Cook Ob/Gyn | 2000 | — |
| +1 | K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient | William A. Cook Australia Pty., Ltd. | 2015 | — |
| +2 | K190199 | SepaSperm Washing Solution, SepaSperm Solution | Kitazato Corporation | 2019 | — |
| +3 | K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2022 | — |
| +4 | K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | 2024 | — |
| +3 | K192644 | GM501 SpermAir and GM501 SpermActive | Hamilton Thorne Incorporated | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient | 2015 | 4 |
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, K152782 (William A. Cook Australia Pty., Ltd., 2015) has gone furthest, with 4 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/K002383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002383: Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002383
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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