510(k) · Cleared
ClearedSynvitro Hyadase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicult A/S · MQL Media, Reproductive
Cleared on Jun 24, 2003 as substantially equivalent to K991334 (Medicult A/S, 2000) after a 67-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jun 24, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991334 (2000). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991334 Medi-Cult Hyaluronidase;Medicult A/S · 2000
- This deviceK031228 Synvitro HyadaseMedicult A/S · 2003
- Descendant · cites it directly · 2 of its ownK060699 Synvitro Cumulase (Hyaluronidase Medium)Medicult A/S · 2006
- Descendant · cites it directly · 1 of its ownK200680 Synvitro HyadaseOrigio A/S, A Coopersurgical Company · 2020
- Descendant · 2 generations on · 1 of its ownK081639 Icsi CumulaseMedicult A/S · 2008
- Descendant · 2 generations on · 0 of its ownK222606 V-HyadaseVitromed GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK182002 Cumulus RemoverKitazato Corporation · 2018
Most influential descendants
Showing 5 of 5 · See all- K060699Synvitro Cumulase (Hyaluronidase Medium)Medicult A/S · 2006 · cites it directly2descendants
- K200680Synvitro HyadaseOrigio A/S, A Coopersurgical Company · 2020 · cites it directly1descendant
- K081639Icsi CumulaseMedicult A/S · 2008 · 2 generations on1descendant
- K222606V-HyadaseVitromed GmbH · 2023 · 2 generations on0descendants
- K182002Cumulus RemoverKitazato Corporation · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991334 | Medi-Cult Hyaluronidase; | Medicult A/S | 2000 | — |
| 0 (this device) | K031228 | Synvitro Hyadase | Medicult A/S | 2003 | — |
| +1 | K060699 | Synvitro Cumulase (Hyaluronidase Medium) | Medicult A/S | 2006 | — |
| +1 | K200680 | Synvitro Hyadase | Origio A/S, A Coopersurgical Company | 2020 | — |
| +2 | K081639 | Icsi Cumulase | Medicult A/S | 2008 | — |
| +2 | K222606 | V-Hyadase | Vitromed GmbH | 2023 | — |
| +3 | K182002 | Cumulus Remover | Kitazato Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQL device
- #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991334 | Medi-Cult Hyaluronidase;Summary page 2…ryos, the fertilisation rate and the cleavage rate. Based on these studies it is concluded that SynVitroO Hyadase is substantial equivalent to Medi-Cult Hyaluronidase ( K 99 1334) and is effective for denuding oocytes prior to ICSI. During our studies there has been no registered complaints and no evidence… | 2000 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQL
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQL
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQL
3in 2025
MAUDE reports naming product code MQL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 212 | 0 | 0 |
| 2008 | 12 | 151 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 235 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 253 | 1 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 5 | 142 | 0 | 3 |
| 2015 | 7 | 87 | 0 | 0 |
| 2016 | 12 | 170 | 0 | 2 |
| 2017 | 10 | 113 | 0 | 0 |
| 2018 | 4 | 94 | 0 | 0 |
| 2019 | 6 | 170 | 0 | 0 |
| 2020 | 8 | 257 | 1 | 0 |
| 2021 | 1 | — | 2 | 0 |
| 2022 | 3 | 316 | 1 | 0 |
| 2023 | 5 | 199 | 1 | 1 |
| 2024 | 12 | 195 | 0 | 6 |
| 2025 | 9 | 225 | 0 | 3 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
For the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031228: Synvitro Hyadase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031228
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026