510(k) · Cleared
ClearedSequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Corporation · MQL Media, Reproductive
Cleared on Oct 23, 2020 as substantially equivalent to K153290 (William A. Cook Australia Pty., Ltd., 2016) after a 263-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Oct 23, 2020
- Review
- 263 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002385 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK002385 Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook…Cook Ob/Gyn · 2000
- 1 generation backK153290 Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium…William A. Cook Australia Pty., Ltd. · 2016
- This deviceK200249 Sequential Culture Media (Fertilization Medium [without HSA/rHA…Kitazato Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf… | Cook Ob/Gyn | 2000 | — |
| −1 | K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF… | William A. Cook Australia Pty., Ltd. | 2016 | — |
| 0 (this device) | K200249 | Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA… | Kitazato Corporation | 2020 | — |
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 |
|---|---|---|---|
| * | K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…Summary page 5…Class II 5. Predicate Device Device Name: Sydney IVF Fertilization Medium, Cleavage Medium, Blastocyst Medium 510(k) Number: K153290 Manufacturer: Cook Medical, Inc. The predicate device has not been subject to a design-related recall. 6. Dev… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K153290.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Sequential Culture Media consists of Fertilization Medium, Cleavage Medium, and Blastocyst Medium that are intended to be used sequentially from fertilization to the blastocyst stage of development. The intended uses of the Fertilization Medium, Cleavage Medium, and Blastocyst Medium are as follows: Fertilization medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm insertion (ICSI) procedures and culture to the two…
Read the full statement (129 words)
Sequential Culture Media consists of Fertilization Medium, Cleavage Medium, and Blastocyst Medium that are intended to be used sequentially from fertilization to the blastocyst stage of development. The intended uses of the Fertilization Medium, Cleavage Medium, and Blastocyst Medium are as follows:
Fertilization medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm insertion (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.
Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage to the 8-cell stage of development. Cleavage Medium is not intended for transferring embryos to the uterine cavity
Blastocyst Medium is intended for culture from the 8-cell stage to the blastocyst stage of development. Blastocyst Medium is not intended for transferring embryos to the uterine cavity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200249: Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200249
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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