# K173624: ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Mar 2, 2018 after 98 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 K002836 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002836: Media for Gamete Preparation and Embryo Culture, Sage Biopharma (2000) Summary page 4.

## Indications for use
ORIGIO® Handling™ is intended for in vitro procedures involving handling and micromanipulation of gametes and embryos outside the CO2 incubator. Indication includes oocyte retrieval including follicle flushing, gamete (oocyte/sperm) and embryo washing, and micromanipulation procedures including Intra Cytoplasmic Sperm Injection (ICSI), assisted hatching and trophectoderm biopsy.

Source page: https://510kreport.com/device/K173624
Methodology: https://510kreport.com/methodology