510(k) · Cleared
ClearedCumulus Remover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Corporation · MQL Media, Reproductive
Cleared on Oct 23, 2018 as substantially equivalent to K081639 (Medicult A/S, 2008) after an 89-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 23, 2018
- Review
- 89 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991334 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK991334 Medi-Cult Hyaluronidase;Medicult A/S · 2000
- 3 generations backK031228 Synvitro HyadaseMedicult A/S · 2003
- 2 generations backK060699 Synvitro Cumulase (Hyaluronidase Medium)Medicult A/S · 2006
- 1 generation backK081639 Icsi CumulaseMedicult A/S · 2008
- This deviceK182002 Cumulus RemoverKitazato Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991334 | Medi-Cult Hyaluronidase; | Medicult A/S | 2000 | — |
| −3 | K031228 | Synvitro Hyadase | Medicult A/S | 2003 | — |
| −2 | K060699 | Synvitro Cumulase (Hyaluronidase Medium) | Medicult A/S | 2006 | — |
| −1 | K081639 | Icsi Cumulase | Medicult A/S | 2008 | — |
| 0 (this device) | K182002 | Cumulus Remover | Kitazato Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K081639 | Icsi CumulaseSummary page 4…: 21 CFR 884.6180 Product code: MQL (Media, Reproductive) Regulatory class: II 5. Predicate Device ICSI Cumulase (K081639) manufactured by MediCult a/s. This predicate device is now branded by Origio a/s and has not been subject to any design relat… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
Cumulus Remover is 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/K182002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182002: Cumulus Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182002
Report an extraction error
Are you the manufacturer?
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