# K072607: Lyophilized Early Cleavage Medium (Ecm) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jan 25, 2008 after 130 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 K033462 (2004). 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)
- K033462: Early Cleavage Medium (Ecm), Irvine Scientific Sales Co., Inc. (2004) Summary page 1.

## Indications for use
Lyophilized Early Cleavage Medium Kit is for use in assisted reproduction technology (ART) that involved the manipulation of gametes or embryos. Specifically, Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium from fertilization through day three (3) of embryo development.

Source page: https://510kreport.com/device/K072607
Methodology: https://510kreport.com/methodology