# K030490: ISM1+, IMS2+, and Utm+

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Aug 20, 2003 after 187 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000625 (2000). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000625: Scandinavian Ivf Sciences AB, G1.2, Vitrolife AB/Scandinavian Ivf Sciences AB (2000) Summary page 2.
- K000619: Scandinavian Ivf Sciences AB, G2.2, Vitrolife AB/Scandinavian Ivf Sciences AB (2000) Summary page 2.

## Most influential descendants
- K080473: Embryoassist and Embryoassist with Phenol Red (2008), 2 descendants of its own
- K120136: Embryogen (2012), 1 descendant of its own
- K140317: Embryogen (2014), 0 descendants of its own

## Indications for use
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+.

Source page: https://510kreport.com/device/K030490
Methodology: https://510kreport.com/methodology