510(k) · Cleared
ClearedGiftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gimbo Medical Technology Shenzhen Co., Ltd. · MQL Media, Reproductive
Cleared on Jun 13, 2024 after a 146-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 13, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK240149 Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™…Gimbo Medical Technology Shenzhen Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK242107 CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience®…Casebioscience, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252672 CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc. · 2026
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 |
|---|---|---|---|---|---|
| 0 (this device) | K240149 | Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™… | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024 | — |
| +1 | K242107 | CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF… | Casebioscience, Inc. | 2025 | — |
| +2 | K252672 | CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) | Casebioscience, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242107 | CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC)… | 2025 | 1 |
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, K242107 (Casebioscience, Inc., 2025) 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. 2024, 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?
Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development. Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity. Giftlife Blastocyst Medium is…
Read the full statement (116 words)
Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.
Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity.
Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity.
Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K240149 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240149: Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240149
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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