# K042495: Cumulase

- Pathway: 510(k) (Traditional)
- Applicant: Halozyme Therapeutics, Inc.
- Decided: Apr 14, 2005 after 212 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 K991334 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991334: Medi-Cult Hyaluronidase;, Medicult A/S (2000) Summary page 1.

## Most influential descendants
- K081639: Icsi Cumulase (2008), 1 descendant of its own
- K182002: Cumulus Remover (2018), 0 descendants of its own

## Indications for use
CumulaseTM is indicated for use in removing the cumulus matrix surrounding oocytes in preparation for assisted reproduction technology (ART) procedures.

Source page: https://510kreport.com/device/K042495
Methodology: https://510kreport.com/methodology