510(k) · Cleared
Recalled · Class II · 2023LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Global Group, LLC · MQL Media, Reproductive
Cleared on Feb 17, 2015 after a 124-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 17, 2015
- Review
- 124 days
- Class
- Class II
- Product code
- MQL
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK142991 LifeGlobal Global Total w/HSA, LifeGlobal Global Total for…Life Global Group, LLC · 2015
- Descendant · cites it directly · 1 of its ownK200408 VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium…Shenzhen Vitavitro Biotech Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK190383 GM501 WashHamilton Thorne, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK251637 Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK213293 V-Hepes PlusVitromed Langenfeld · 2022
- Descendant · 2 generations on · 0 of its ownK192503 GM501 Wash with Phenol Red and GentamicinHamilton Thorne Incorporated · 2020
Most influential descendants
Showing 5 of 5 · See all- K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…Shenzhen Vitavitro Biotech Co., Ltd. · 2020 · cites it directly1descendant
- K190383GM501 WashHamilton Thorne, Inc. · 2019 · cites it directly1descendant
- K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025 · 2 generations on0descendants
- K213293V-Hepes PlusVitromed Langenfeld · 2022 · cites it directly0descendants
- K192503GM501 Wash with Phenol Red and GentamicinHamilton Thorne Incorporated · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization… | Life Global Group, LLC | 2015 | — |
| +1 | K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro®… | Shenzhen Vitavitro Biotech Co., Ltd. | 2020 | — |
| +1 | K190383 | GM501 Wash | Hamilton Thorne, Inc. | 2019 | — |
| +2 | K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]… | Donnevie Medical Technology (Shanghai) Co., Ltd. | 2025 | — |
| +1 | K213293 | V-Hepes Plus | Vitromed Langenfeld | 2022 | — |
| +2 | K192503 | GM501 Wash with Phenol Red and Gentamicin | Hamilton Thorne Incorporated | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2023 | Class II | Z-1089-2024 | Under Investigation by firm | The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage. |
| Feb 13, 2023 | Class II | Z-1348-2023 | Labeling Change Control | It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200408 (Shenzhen Vitavitro Biotech Co., Ltd., 2020) has gone furthest, with 1 descendant 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. 2015, 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?
Culture of Embryos from zygote to blastocyst, embryo transfer
Oocyte culture and fertilization
Oocyte and embryo washing, Manipulation, fertilization by intracytoplasmic sperm injection (ICSI), embryo transfer
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142991: LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142991
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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