# K033462: Early Cleavage Medium (Ecm)

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jan 15, 2004 after 76 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K072607: Lyophilized Early Cleavage Medium (Ecm) Kit (2008), 0 descendants of its own

## Indications for use
Early Cleavage Medium (ECM) is intended for use in assisted reproductive procedures, which include gamete and embryo manipulation. These procedures include the use of ECM as a culture medium through day 3 of development.

Source page: https://510kreport.com/device/K033462
Methodology: https://510kreport.com/methodology