# K081639: Icsi Cumulase

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Sep 19, 2008 after 100 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: 3 generations back to K991334 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060699: Synvitro Cumulase (Hyaluronidase Medium), Medicult A/S (2006) Summary page 1.
- K042495: Cumulase, Halozyme Therapeutics, Inc. (2005) Summary page 1.

## Most influential descendants
- K182002: Cumulus Remover (2018), 0 descendants of its own

## Indications for use
ICSI Cumulase ® is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

Source page: https://510kreport.com/device/K081639
Methodology: https://510kreport.com/methodology