510(k) · Cleared
ClearedARTSMedia In Vitro Culture Medium (AM-IVC Medium)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artsmedia Denmark Aps · MQL Media, Reproductive
Cleared on Feb 10, 2023 as substantially equivalent to K133707 (Origio A/S, 2014) after a 336-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Feb 10, 2023
- Review
- 336 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K112083 (2012). No later device cites it as a predicate yet.
- Root · 2 generations backK112083 Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total…<Genx> Intl., Inc. · 2012
- 1 generation backK133707 Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein…Origio A/S · 2014
- This deviceK220715 ARTSMedia In Vitro Culture Medium (AM-IVC Medium)Artsmedia Denmark Aps · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark Aps | 2023 | — |
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 |
|---|---|---|---|
| * | K133707 | Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein SupplementsSummary page 4…84.6180 Class Class II Product Code MQL (Media, Reproductive) Predicate Device K133707 ORIGIO a/s SAGE 1-StepTM supplemented with Hu… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K133707.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for 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/K220715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220715: ARTSMedia In Vitro Culture Medium (AM-IVC Medium).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220715
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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