# K133912: Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav, Origio Sequential Cleav, Origio

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: May 14, 2014 after 142 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 K002385 (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)
- K002385: Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium,, Cook Ob/Gyn (2000) Summary page 1.

## Indications for use
ORIGIO® Sequential FertTM is for the fertilization of oocytes in vitro. ORIGIO® Sequential CleavTM is for the culture of embryos until the 2-8 cell stage. ORIGIO® Sequential CleavTM can also be used for embryo transfer at day 2 or 3.

Source page: https://510kreport.com/device/K133912
Methodology: https://510kreport.com/methodology