510(k) · Cleared
ClearedG-Mops G5 Series
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 Sep 17, 2008 as substantially equivalent to K021893 (Vitrolife Sweden AB, 2002) after a 152-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Sep 17, 2008
- Review
- 152 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021893 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021893 G-Mops, Model 10030Vitrolife Sweden AB · 2002
- This deviceK081115 G-Mops G5 SeriesVitrolife Sweden AB · 2008
- Descendant · cites it directly · 0 of its ownK202862 Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB · 2021
- Descendant · cites it directly · 0 of its ownK121128 Multipurpose Handling MediumIrvine Scientific Sales Co., Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021893 | G-Mops, Model 10030 | Vitrolife Sweden AB | 2002 | — |
| 0 (this device) | K081115 | G-Mops G5 Series | Vitrolife Sweden AB | 2008 | — |
| +1 | K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | 2021 | — |
| +1 | K121128 | Multipurpose Handling Medium | Irvine Scientific Sales Co., Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K021893 | G-Mops, Model 10030Summary page 1…Classification Name: Reproductive Media and Supplements (21 C.F.R. § 884.6180) Predicate Device: G-MOPSTM (K021893) Description of the Device: The IVF Media GIII Series have been on the market for a… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
G-MOPSTM is indicated for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.
G-MOPSTM PLUS is indicated for handling/manipulating oocytes and embryos in ambient atmosphere.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081115: G-Mops G5 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081115
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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