510(k) · Cleared
ClearedCryotop®US-flash and Cryotop®US-scoop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Corporation · MQK Labware, Assisted Reproduction
Cleared on Nov 9, 2018 as substantially equivalent to K153027 (Kitazato Biopharma Co., Ltd., 2016) after a 158-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Nov 9, 2018
- Review
- 158 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K041562 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- 3 generations backK090832 Rapid-IVitrolife Sweden AB · 2009
- 2 generations backK122982 CryolockBiotech, Inc. · 2014
- 1 generation backK153027 Cryotop USKitazato Biopharma Co., Ltd. · 2016
- This deviceK181469 Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation · 2018
- Descendant · cites it directly · 0 of its ownK241454 Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR…Guangzhou Hehong Biotech Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB…Guangzhou Hehong Biotech Co., Ltd. · 2025 · cites it directly0descendants
View 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 | K122982 | Cryolock | Biotech, Inc. | 2014 | — |
| −1 | K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016 | — |
| 0 (this device) | K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | 2018 | — |
| +1 | K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY… | Guangzhou Hehong Biotech Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K153027 | Cryotop USSummary page 4…mber: 21 CFR 884.6160 Product Code: MQK (Labware, Assisted Reproduction) Regulatory Class: II 5. Predicate Device Cryotop®US (K153027) manufactured by Kitazato Corporation (formally KITAZATO BIOPHARMA CO., LTD.) This predicate device has not been subject to an… | 2016 |
| † | K171748 | Vitrification Kit and Thawing Kit | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB… | 2025 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K241454 (Guangzhou Hehong Biotech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153027.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Cryotop®US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181469: Cryotop®US-flash and Cryotop®US-scoop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181469
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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