# K170498: Gems Oocyte Retrieval Buffer ORB-20, ORB-50

- Pathway: 510(k) (Traditional)
- Applicant: Genea Biomedx Pty, Ltd.
- Decided: Sep 28, 2017 after 223 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 4.

## Indications for use
Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.

Source page: https://510kreport.com/device/K170498
Methodology: https://510kreport.com/methodology