# K022002: Sydney Ivf Culture Oil

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Aug 12, 2002 after 54 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K170257: Sydney IVF Culture Oil (2017), 0 descendants of its own
- K160142: Mineral Oil (2016), 0 descendants of its own

## Recalls of this device
- Feb 15, 2012 · Not classified · Z-1324-2012: Cook Medical is recalling Sydney IVF Culture Oil due to a number of recent customer complaints that have identified it as a possible cause of embryo degeneration at day 5/6.

## Indications for use
The Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures.

Source page: https://510kreport.com/device/K022002
Methodology: https://510kreport.com/methodology