510(k) · Cleared
ClearedLifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/Hepes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
<Genx> Intl., Inc. · MQL Media, Reproductive
Cleared on May 3, 2012 after a 287-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- May 3, 2012
- Review
- 287 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK112083 Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total…<Genx> Intl., Inc. · 2012
- Descendant · cites it directly · 2 of its ownK133707 Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein…Origio A/S · 2014
- Descendant · 2 generations on · 0 of its ownK220715 ARTSMedia In Vitro Culture Medium (AM-IVC Medium)Artsmedia Denmark Aps · 2023
- Descendant · 2 generations on · 0 of its ownK172197 SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSOrigio A/S · 2017
Most influential descendants
Showing 3 of 3 · See all- K133707Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein SupplementsOrigio A/S · 2014 · cites it directly2descendants
- K220715ARTSMedia In Vitro Culture Medium (AM-IVC Medium)Artsmedia Denmark Aps · 2023 · 2 generations on0descendants
- K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSOrigio A/S · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112083 | Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total… | <Genx> Intl., Inc. | 2012 | — |
| +1 | K133707 | Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements | Origio A/S | 2014 | — |
| +2 | K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark Aps | 2023 | — |
| +2 | K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | Origio A/S | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133707 | Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements | 2014 | 2 |
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?
- Of its descendants, K133707 (Origio A/S, 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
LifeGlobal Global Total:
Culture of human embryos from zygote to blastocyst, and embryo transfer
LifeGlobal Global Total for Fertilization:
Human oocyte culture and fertilization
LifeGlobal Global Total w/HEPES
Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112083: Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/Hepes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112083
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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