510(k) · Cleared
ClearedDewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step 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 27, 2025 as substantially equivalent to K200408 (Shenzhen Vitavitro Biotech Co., Ltd., 2020) after a 90-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 27, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002385 (2000). 5 ancestors in all, the oldest K991395 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002385 Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook…Cook Ob/Gyn · 2000
- 2 generations backK153290 Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium…William A. Cook Australia Pty., Ltd. · 2016
- 1 generation backK200408 VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium…Shenzhen Vitavitro Biotech Co., Ltd. · 2020
- This deviceK251637 Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf… | Cook Ob/Gyn | 2000 | — |
| −2 | K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF… | William A. Cook Australia Pty., Ltd. | 2016 | — |
| −1 | K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro®… | Shenzhen Vitavitro Biotech Co., Ltd. | 2020 | — |
| 0 (this device) | K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]… | Donnevie Medical Technology (Shanghai) Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…Summary page 5…oductive) Regulatory Class: II III. PREDICATE DEVICE VitaVitro Fertilization Medium, VitaVitro Gamete Buffer Medium, VitaVitro Flushing Buffer Medium (K200408) from Shenzhen VitaVitro Biotech Co.,Ltd. The predicate device has not been subject to a design-related recall. IV. DEV… | 2020 |
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 25 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Gamete Buffer is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).
Dewin Follicle Flushing Solution is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.
Dewin One Step Medium is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251637: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251637
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