# K160142: Mineral Oil

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Biopharma Co., Ltd.
- Decided: Apr 21, 2016 after 91 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 K022002 (2002). 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)
- K022002: Sydney Ivf Culture Oil, Cook Urological, Inc. (2002) Summary page 4.

## Indications for use
Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

Source page: https://510kreport.com/device/K160142
Methodology: https://510kreport.com/methodology