# K012123: Nidoil

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Aug 3, 2001 after 28 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 K991351 (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)
- K991351: Ovoil-150, Model 5002, Vitrolife Sweden AB (2000) Summary page 1.

## Indications for use
The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.

Source page: https://510kreport.com/device/K012123
Methodology: https://510kreport.com/methodology