510(k) · Cleared
ClearedCryotop US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kitazato Biopharma Co., Ltd. · MQK Labware, Assisted Reproduction
Cleared on Mar 14, 2016 as substantially equivalent to K122982 (Biotech, Inc., 2014) after a 150-day review. Its family tree reaches back 3 generations to 2004. 3 later devices descend from it.
- Decided
- Mar 14, 2016
- Review
- 150 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K041562 (2004). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- 2 generations backK090832 Rapid-IVitrolife Sweden AB · 2009
- 1 generation backK122982 CryolockBiotech, Inc. · 2014
- This deviceK153027 Cryotop USKitazato Biopharma Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK181469 Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK241454 Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR…Guangzhou Hehong Biotech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK162051 CryotecReprolife, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation · 2018 · cites it directly1descendant
- K241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB…Guangzhou Hehong Biotech Co., Ltd. · 2025 · 2 generations on0descendants
- K162051CryotecReprolife, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041562 | Cryotip | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −2 | K090832 | Rapid-I | Vitrolife Sweden AB | 2009 | — |
| −1 | K122982 | Cryolock | Biotech, Inc. | 2014 | — |
| 0 (this device) | K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016 | — |
| +1 | K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | 2018 | — |
| +2 | K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY… | Guangzhou Hehong Biotech Co., Ltd. | 2025 | — |
| +1 | K162051 | Cryotec | Reprolife, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K122982 | CryolockSummary page 5…oduct Code: MQK Device Class: Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device K122982, CRYOLOCK™, BioTech Inc. 6. Device Description CryotopUS is a cryopreservation storage device that is intended for use in vi… | 2014 |
What descends from it? (3)
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 12 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K181469 (Kitazato Corporation, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122982.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Cryotop®US is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153027: Cryotop US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153027
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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