510(k) · Cleared
ClearedDewin Blastocyst Medium (with HSA and without HSA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Donnevie Medical Technology (Shanghai) Co., Ltd. · MQL Media, Reproductive
Cleared on Aug 4, 2023 as substantially equivalent to K153290 (William A. Cook Australia Pty., Ltd., 2016) after an 84-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 4, 2023
- Review
- 84 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 deviceK231370 Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd. · 2023
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) | K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co., Ltd. | 2023 | — |
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 4…e) Class: Class II 5. Legally Marketed Predicate Device Device name: Sydney IVF Blastocyst Medium 510(k) number: K153290 Manufacturer: William A. Cook Australia Pty, Ltd. The predicate device has not been subject to a design-relat… | 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 23 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. 2023, 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?
Dewin Blastocyst Medium (with HSA and without HSA) is intended for culture from the 8-cell stage to the blastocyst stage of embryo development. Dewin Blastocyst Medium (with HSA and without HSA) is also intended for use in transfer of blastocyst stage embryos into the uterine cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231370: Dewin Blastocyst Medium (with HSA and without HSA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231370
Report an extraction error
Are you the manufacturer?
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