510(k) · Cleared
ClearedVitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Vitavitro Biotech Co., Ltd. · MQL Media, Reproductive
Cleared on Oct 16, 2020 as substantially equivalent to K142991 (Life Global Group, LLC, 2015) and 2 other predicates after a 240-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Oct 16, 2020
- Review
- 240 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002385 (2000). 4 ancestors in all, the oldest K991395 (2000). 1 later device descends from it, 1 citing it directly.
- 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 deviceK200408 VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium…Shenzhen Vitavitro Biotech Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK251637 Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025 · cites it directly0descendants
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) | K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro®… | Shenzhen Vitavitro Biotech Co., Ltd. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA…Summary page 4…l Group, LLC Technologies Australia Pty Ltd 510(k) No. K142991 K991395 K153290 The predicate devices have not been subjected to any design related r… | 2015 |
| * | K991395 | Quinn's HTF Medium, Quinn's HTF Medium with Hepes, Quinn's Basal XI HTF Medium, Quinn's…Summary page 4…Technologies Australia Pty Ltd 510(k) No. K142991 K991395 K153290 The predicate devices have not been subjected to any design related recalls. 5. DEVICE DESCR… | 2000 |
| * | K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…Summary page 4…Technologies Australia Pty Ltd 510(k) No. K142991 K991395 K153290 The predicate devices have not been subjected to any design related recalls. 5. DEVICE DESCRIPTION This submission… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle… | 2025 | 0 |
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.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K251637 (Donnevie Medical Technology (Shanghai) Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142991.
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?
VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization.
VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).
VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200408: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200408
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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