510(k) · Cleared
ClearedSepaSperm Washing Solution, SepaSperm Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Corporation · MQL Media, Reproductive
Cleared on Sep 26, 2019 as substantially equivalent to K152782 (William A. Cook Australia Pty., Ltd., 2015) after a 234-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Sep 26, 2019
- Review
- 234 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002383 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002383 Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm…Cook Ob/Gyn · 2000
- 1 generation backK152782 Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf…William A. Cook Australia Pty., Ltd. · 2015
- This deviceK190199 SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation · 2019
- Descendant · cites it directly · 1 of its ownK212410 VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumShenzhen Vitavitro Biotech Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK241095 ARTSMedia Semen Wash MediumArtsmedia Denmark Aps · 2024
- Descendant · cites it directly · 0 of its ownK192644 GM501 SpermAir and GM501 SpermActiveHamilton Thorne Incorporated · 2020
Most influential descendants
Showing 3 of 3 · See all- K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumShenzhen Vitavitro Biotech Co., Ltd. · 2022 · cites it directly1descendant
- K241095ARTSMedia Semen Wash MediumArtsmedia Denmark Aps · 2024 · 2 generations on0descendants
- K192644GM501 SpermAir and GM501 SpermActiveHamilton Thorne Incorporated · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K190199 | SepaSperm Washing Solution, SepaSperm Solution | Kitazato Corporation | 2019 | — |
| +1 | K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2022 | — |
| +2 | K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | 2024 | — |
| +1 | K192644 | GM501 SpermAir and GM501 SpermActive | Hamilton Thorne Incorporated | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf SpermientSummary page 4…Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit, Sydney IVF Spermient 510(k) Number: K152782 Manufacturer: William A. Cook Australia Pty Ltd. Regulatory Class: Class II… | 2015 |
What descends from it? (3)
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 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212410 (Shenzhen Vitavitro Biotech Co., Ltd., 2022) has gone furthest, with 1 descendant 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. 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?
SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reproduction procedures.
SepaSperm Washing Solution is not intended for use in intrauterine insemination procedures.
SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190199: SepaSperm Washing Solution, SepaSperm Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190199
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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