510(k) · Cleared
ClearedMedi-Cult Universal Ivf-Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicult A/S · MQL Media, Reproductive
Cleared on Jul 20, 2000 after a 463-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Jul 20, 2000
- Review
- 463 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK991279 Medi-Cult Universal Ivf-MediumMedicult A/S · 2000
- Descendant · cites it directly · 3 of its ownK061309 EmbryoassistMedicult A/S · 2007
- Descendant · cites it directly · 2 of its ownK080473 Embryoassist and Embryoassist with Phenol RedMedicult A/S · 2008
- Descendant · 2 generations on · 1 of its ownK120136 EmbryogenOrigio A/S · 2012
- Descendant · cites it directly · 1 of its ownK041284 Medicult Ivm SystemMedicult A/S · 2004
- Descendant · 3 generations on · 0 of its ownK140317 EmbryogenOrigio A/S · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061309EmbryoassistMedicult A/S · 2007 · cites it directly3descendants
- K080473Embryoassist and Embryoassist with Phenol RedMedicult A/S · 2008 · cites it directly2descendants
- K120136EmbryogenOrigio A/S · 2012 · 2 generations on1descendant
- K041284Medicult Ivm SystemMedicult A/S · 2004 · cites it directly1descendant
- K140317EmbryogenOrigio A/S · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991279 | Medi-Cult Universal Ivf-Medium | Medicult A/S | 2000 | — |
| +1 | K061309 | Embryoassist | Medicult A/S | 2007 | — |
| +1 | K080473 | Embryoassist and Embryoassist with Phenol Red | Medicult A/S | 2008 | — |
| +2 | K120136 | Embryogen | Origio A/S | 2012 | — |
| +1 | K041284 | Medicult Ivm System | Medicult A/S | 2004 | — |
| +3 | K140317 | Embryogen | Origio A/S | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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?
The FDA summary names no predicate by number.
What descends from it? (6)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061309 (Medicult A/S, 2007) has gone furthest, with 3 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.
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?
Medi-Cult Universal IVF Medium is used for the fertilization of human oocytes and culture of fertilized oocytes up to the 4-6-cell stage (day 2 after insemination).
Medi-Cult Universal IVF Medium can also be used as vehicle during embryo transfer.
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/K991279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991279: Medi-Cult Universal Ivf-Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991279
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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