510(k) · Cleared
ClearedGx-IVF, Gx-TL, Gx-MOPS PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife Sweden AB · MQL Media, Reproductive
Cleared on May 14, 2021 as substantially equivalent to K081116 (Vitrolife Sweden AB, 2008) and 2 other predicates after a 228-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- May 14, 2021
- Review
- 228 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K034063 (2004). 9 ancestors in all, the oldest K021893 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK034063 Multiblast MediumIrvine Scientific Sales Co., Inc. · 2004
- 3 generations backK072609 Single Step MediumIrvine Scientific Sales Co., Inc. · 2008
- 2 generations backK121572 Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
- 1 generation backK133568 G-TLVitrolife, Inc. · 2014
- This deviceK202862 Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K034063 | Multiblast Medium | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −3 | K072609 | Single Step Medium | Irvine Scientific Sales Co., Inc. | 2008 | — |
| −2 | K121572 | Continuous Single Culture Complete | Irvine Scientific Sales Co., Inc. | 2012 | — |
| −1 | K133568 | G-TL | Vitrolife, Inc. | 2014 | — |
| 0 (this device) | K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K081116 | G-Ivf G5 SeriesSummary page 4…ber: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Product Code: MQL (Media, Reproductive) 4. Predicate Device(s): G-IVF™ PLUS (K081116) manufactured by Vitrolife Sweden AB G-TL™ (K133568) manufactured by… | 2008 |
| * | K133568 | G-TLSummary page 4…Reproductive) 4. Predicate Device(s): G-IVF™ PLUS (K081116) manufactured by Vitrolife Sweden AB G-TL™ (K133568) manufactured by Vitrolife Sweden AB G-MOPS™ PLUS (K081115) manufactured by Vitrolife… | 2014 |
| * | K081115 | G-Mops G5 SeriesSummary page 4…ife Sweden AB G-TL™ (K133568) manufactured by Vitrolife Sweden AB G-MOPS™ PLUS (K081115) manufactured by Vitrolife Sweden AB The predicate devices have not been subject to a design relate… | 2008 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K081116.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination.
Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer.
Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202862: Gx-IVF, Gx-TL, Gx-MOPS PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202862
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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