510(k) · Cleared
ClearedVitriGuard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origio A/S · MQK Labware, Assisted Reproduction
Cleared on Jun 25, 2020 as substantially equivalent to K181461 (Vitrolife Sweden AB, 2019) after an 87-day review. Its family tree reaches back 4 generations to 2004. 2 later devices descend from it.
- Decided
- Jun 25, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K041562 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- 3 generations backK090832 Rapid-IVitrolife Sweden AB · 2009
- 2 generations backK140207 Rapid-I KitVitrolife Sweden AB · 2014
- 1 generation backK181461 Rapid-i™ KitVitrolife Sweden AB · 2019
- This deviceK200815 VitriGuardOrigio A/S · 2020
- Descendant · cites it directly · 0 of its ownK241341 cryo-GO Vitrification DeviceFujifilm Irvine Scientific · 2024
- Descendant · cites it directly · 0 of its ownK233177 Nest VT Vitrification DeviceCook Incorporated · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041562 | Cryotip | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −3 | K090832 | Rapid-I | Vitrolife Sweden AB | 2009 | — |
| −2 | K140207 | Rapid-I Kit | Vitrolife Sweden AB | 2014 | — |
| −1 | K181461 | Rapid-i™ Kit | Vitrolife Sweden AB | 2019 | — |
| 0 (this device) | K200815 | VitriGuard | Origio A/S | 2020 | — |
| +1 | K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 2024 | — |
| +1 | K233177 | Nest VT Vitrification Device | Cook Incorporated | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 MQK? 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 MQK device
- #1 K241626 SperSort™ Sperm Sorting Chip (IPG02)score 10.1 · 5 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 |
|---|---|---|---|
| * | K181461 | Rapid-i™ KitSummary page 4…MQK (Labware, Assisted Reproduction) Regulatory Class: Class II Review Panel: Obstetrics/Gynecology PREDICATE DEVICE INFORMATION Vitrolife Rapid-I (K181461). The predicate device has not been subject to a design-related recall. DEVICE DESCRIPTION VitriGuard is a sterile, single-use… | 2019 |
| † | K162833 | VitriGuard | 2017 |
What descends from it? (2)
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K241341 (Fujifilm Irvine Scientific, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MQK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQK
259in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQK
1in 2025
MAUDE reports naming product code MQK, 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 | 1 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 454 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 6 | 270 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 4 | 154 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 4 | 163 | 0 | 0 |
| 2025 | 3 | 259 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VitriGuard is intended for use as a cryopreservation storage device in vitrification procedures and indicated to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200815: VitriGuard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200815
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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