# K133707: Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Apr 16, 2014 after 133 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 K112083 (2012). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112083: Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/Hepes, <Genx> Intl., Inc. (2012) Summary page 1.

## Most influential descendants
- K220715: ARTSMedia In Vitro Culture Medium (AM-IVC Medium) (2023), 0 descendants of its own
- K172197: SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (2017), 0 descendants of its own

## Indications for use
These products are intended for the in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The media can also be used for transfer.

Source page: https://510kreport.com/device/K133707
Methodology: https://510kreport.com/methodology