510(k) · Cleared
ClearedCryotip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Scientific Sales Co., Inc. · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Aug 9, 2004 after a 60-day review. The FDA summary names no predicate by number. 19 later devices descend from it.
- Decided
- Aug 9, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 4 citing it directly.
- This deviceK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- Descendant · cites it directly · 17 of its ownK090832 Rapid-IVitrolife Sweden AB · 2009
- Descendant · cites it directly · 8 of its ownK122982 CryolockBiotech, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK140207 Rapid-I KitVitrolife Sweden AB · 2014
- Descendant · 3 generations on · 3 of its ownK181461 Rapid-i™ KitVitrolife Sweden AB · 2019
- Descendant · 2 generations on · 3 of its ownK153027 Cryotop USKitazato Biopharma Co., Ltd. · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K090832Rapid-IVitrolife Sweden AB · 2009 · cites it directly17descendants
- K122982CryolockBiotech, Inc. · 2014 · cites it directly8descendants
- K140207Rapid-I KitVitrolife Sweden AB · 2014 · 2 generations on4descendants
- K181461Rapid-i™ KitVitrolife Sweden AB · 2019 · 3 generations on3descendants
- K153027Cryotop USKitazato Biopharma Co., Ltd. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041562 | Cryotip | Irvine Scientific Sales Co., Inc. | 2004 | — |
| +1 | K090832 | Rapid-I | Vitrolife Sweden AB | 2009 | — |
| +1 | K122982 | Cryolock | Biotech, Inc. | 2014 | — |
| +2 | K140207 | Rapid-I Kit | Vitrolife Sweden AB | 2014 | — |
| +3 | K181461 | Rapid-i™ Kit | Vitrolife Sweden AB | 2019 | — |
| +2 | K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 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 MQH? 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 MQH device
- #1 K250838 Denudation Pipettesscore 9.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (19)
See all 194 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?
- Of its descendants, K090832 (Vitrolife Sweden AB, 2009) has gone furthest, with 17 descendants of its own.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQH
Too few MQH 510(k)s in any year since 2007 to give a median.
Recalls per year · MQH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQH
10in 2021
MAUDE reports naming product code MQH, 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 | 0 | — | 1 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CryoTip is a cryopreservation device that is intended to be used to contain, freeze and maintain oocytes and/or embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041562: Cryotip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041562
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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