# K031228: Synvitro Hyadase

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Jun 24, 2003 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
Longest line of descent: 1 generation back to K991334 (2000). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 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 2.

## Most influential descendants
- K060699: Synvitro Cumulase (Hyaluronidase Medium) (2006), 2 descendants of its own
- K200680: Synvitro Hyadase (2020), 1 descendant of its own
- K081639: Icsi Cumulase (2008), 1 descendant of its own
- K222606: V-Hyadase (2023), 0 descendants of its own
- K182002: Cumulus Remover (2018), 0 descendants of its own

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

Source page: https://510kreport.com/device/K031228
Methodology: https://510kreport.com/methodology