# K172197: SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Oct 13, 2017 after 84 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: 2 generations back to K112083 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133707: Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements, Origio A/S (2014) Summary page 4.

## Indications for use
The product is intended for in vitro culture of human embryos following fertilization until Day 5/6 of development. The media can also be used for embryo transfer

Source page: https://510kreport.com/device/K172197
Methodology: https://510kreport.com/methodology