510(k) · Cleared
ClearedHSV Straw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryo Bio System · MQK Labware, Assisted Reproduction
Cleared on Oct 6, 2010 as substantially equivalent to K041562 (Irvine Scientific Sales Co., Inc., 2004) and 1 other predicate after a 426-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Oct 6, 2010
- Review
- 426 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K041562 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- 1 generation backK090832 Rapid-IVitrolife Sweden AB · 2009
- This deviceK092398 HSV StrawCryo Bio System · 2010
- Descendant · cites it directly · 0 of its ownK140072 Cryotop (R) SCKitazato Biopharma Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK112695 CryotopKitazato Biopharma Co;Ltd · 2012
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 |
|---|---|---|---|---|---|
| −2 | K041562 | Cryotip | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −1 | K090832 | Rapid-I | Vitrolife Sweden AB | 2009 | — |
| 0 (this device) | K092398 | HSV Straw | Cryo Bio System | 2010 | — |
| +1 | K140072 | Cryotop (R) SC | Kitazato Biopharma Co., Ltd. | 2014 | — |
| +1 | K112695 | Cryotop | Kitazato Biopharma Co;Ltd | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K041562 | CryotipSummary page 2…Sweden 51 0(k)# K092398 K041562 K090832 The HSV Straw is a The Cryotip' TM is a… | 2004 |
| * | K090832 | Rapid-I Cleared while this submission was under review Summary page 2…Sweden 51 0(k)# K092398 K041562 K090832 The HSV Straw is a The Cryotip' TM is a Rapid-i'TM is a cryopreservat… | 2009 |
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 6 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K140072 (Kitazato Biopharma Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K041562.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 HSV Straw 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/K092398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092398: HSV Straw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092398
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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