# K011938: Oil for Embryo Culture

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 18, 2001 after 27 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jan 16, 2023 · Class II · Z-1314-2023: Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

## Indications for use
Oil for Embryo Culture is intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.

Source page: https://510kreport.com/device/K011938
Methodology: https://510kreport.com/methodology