# K021358: Embryo Biopsy Medium

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 5, 2002 after 67 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
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
- K060983: Biopsy Medium, Model Ref 1062 (2006), 0 descendants of its own
- K033101: G-PGD (2004), 0 descendants of its own

## Indications for use
Embryo Biopsy Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of embryos. Specifically, Embryo Biopsy Medium is intended for use as a temporary culture medium during embryo biopsy blastomere removal procedures.

Source page: https://510kreport.com/device/K021358
Methodology: https://510kreport.com/methodology