510(k) · Cleared
ClearedDewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
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 Apr 10, 2025 as substantially equivalent to K171748 (Kitazato Corporation, 2017) after a 225-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Apr 10, 2025
- Review
- 225 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000309 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK000309 Blastocyst Freeze Medium, Blastocyst Thaw MediumIrvine Scientific Sales Co., Inc. · 2000
- 5 generations backK032154 G-Freezekit BlastVitrolife AB · 2004
- 4 generations backK073522 Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 2008
- 3 generations backK093273 Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
- 2 generations backK160006 Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze…Irvine Scientific · 2016 · Recalled
- 1 generation backK171748 Vitrification Kit and Thawing KitKitazato Corporation · 2017
- This deviceK242561 Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)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 |
|---|---|---|---|---|---|
| −6 | K000309 | Blastocyst Freeze Medium, Blastocyst Thaw Medium | Irvine Scientific Sales Co., Inc. | 2000 | — |
| −5 | K032154 | G-Freezekit Blast | Vitrolife AB | 2004 | — |
| −4 | K073522 | Vitrification Kit & Vitrification Warming Kit | Sage In-Vitro Fertilization, Inc. | 2008 | — |
| −3 | K093273 | Vit Kit - Freeze and Thaw | Irvine Scientific Sales Co., Inc. | 2010 | — |
| −2 | K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit… | Irvine Scientific | 2016 | 2 |
| −1 | K171748 | Vitrification Kit and Thawing Kit | Kitazato Corporation | 2017 | — |
| 0 (this device) | K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K171748 | Vitrification Kit and Thawing KitSummary page 5…ion Number: 884.6180 Product Code: MQL (Media, Reproductive) Regulatory Class: II III. PREDICATE DEVICE Vitrification Kit and Thawing Kit (K171748) from Kitazato Corporation. The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION… | 2017 |
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 6 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 5 other devices also cite its predicate K171748.
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 Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Dewin Thawing Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242561 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242561: Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K242561
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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