# K072609: Single Step Medium

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Feb 12, 2008 after 148 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 K034063 (2004). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034063: Multiblast Medium, Irvine Scientific Sales Co., Inc. (2004) Summary page 1.
- K053552: Global Fertilization, Embryo Culture and Transfer Media, <Genx> Intl., Inc. (2006) Summary page 1.

## Most influential descendants
- K121572: Continuous Single Culture Complete (2012), 8 descendants of its own
- K133568: G-TL (2014), 4 descendants of its own
- K191063: 1-Step Culture Medium (2019), 1 descendant of its own
- K170681: Continuous Single Culture -NX (CSCM-NX) (2017), 1 descendant of its own
- K202862: Gx-IVF, Gx-TL, Gx-MOPS PLUS (2021), 0 descendants of its own

## Indications for use
Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.

Source page: https://510kreport.com/device/K072609
Methodology: https://510kreport.com/methodology