510(k) · Cleared
ClearedISM1+, IMS2+, and Utm+
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 Aug 20, 2003 as substantially equivalent to K000625 (Vitrolife AB/Scandinavian Ivf Sciences AB, 2000) and 1 other predicate after a 187-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Aug 20, 2003
- Review
- 187 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000625 (2000). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000625 Scandinavian Ivf Sciences AB, G1.2Vitrolife AB/Scandinavian Ivf Sciences AB · 2000
- This deviceK030490 ISM1+, IMS2+, and Utm+Medicult A/S · 2003
- 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 · 3 generations on · 0 of its ownK140317 EmbryogenOrigio A/S · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000625 | Scandinavian Ivf Sciences AB, G1.2 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000 | — |
| 0 (this device) | K030490 | ISM1+, IMS2+, and Utm+ | Medicult A/S | 2003 | — |
| +1 | K080473 | Embryoassist and Embryoassist with Phenol Red | Medicult A/S | 2008 | — |
| +2 | K120136 | Embryogen | Origio A/S | 2012 | — |
| +3 | K140317 | Embryogen | Origio A/S | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K000625 | Scandinavian Ivf Sciences AB, G1.2Summary page 2…ctiveness of the product for its intended use is shown in the present submission and the products are substantially equivalent to the predicated devices G1.2 media ( K 000625) and G2.2 media ( K 000619). ./President R & R REGISTRATIONS P.O. Box 262069 San Diego, Ca 92 13 1 6 19… | 2000 |
| * | K000619 | Scandinavian Ivf Sciences AB, G2.2Summary page 2…s intended use is shown in the present submission and the products are substantially equivalent to the predicated devices G1.2 media ( K 000625) and G2.2 media ( K 000619). ./President R & R REGISTRATIONS P.O. Box 262069 San Diego, Ca 92 13 1 6 19-586-0751… | 2000 |
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 |
|---|---|---|---|
| K080473 | Embryoassist and Embryoassist with Phenol Red | 2008 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K080473 (Medicult A/S, 2008) 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.
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?
ISMl+
For culture of embryos. To be used in culture after fertilization in Universal IVF Medium (K 991279) up to Day 3 to 6- to 8-cell stage, followed by extended culture in ISM2+ or by transfer in UTM+.
ISM2+
For culture of embryos. To be used in culture from 6- to 8-cell stage on Day 3 to blastocyst stage on Day 5, followed by transfer in UTM+. ISM2+ shall be used after ISMI+.
UTM+
For transfer of embryos cultured in ISM1+ or ISM2+.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030490: ISM1+, IMS2+, and Utm+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030490
Report an extraction error
Are you the manufacturer?
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