510(k) · Cleared
ClearedRapid-I Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife Sweden AB · MQK Labware, Assisted Reproduction
Cleared on Dec 18, 2014 as substantially equivalent to K090832 (Vitrolife Sweden AB, 2009) after a 324-day review. Its family tree reaches back 2 generations to 2004. 4 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 324 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041562 (2004). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- 1 generation backK090832 Rapid-IVitrolife Sweden AB · 2009
- This deviceK140207 Rapid-I KitVitrolife Sweden AB · 2014
- Descendant · cites it directly · 3 of its ownK181461 Rapid-i™ KitVitrolife Sweden AB · 2019
- Descendant · 2 generations on · 2 of its ownK200815 VitriGuardOrigio A/S · 2020
- Descendant · 3 generations on · 0 of its ownK241341 cryo-GO Vitrification DeviceFujifilm Irvine Scientific · 2024
- Descendant · 3 generations on · 0 of its ownK233177 Nest VT Vitrification DeviceCook Incorporated · 2024
Most influential descendants
Showing 4 of 4 · See all- K181461Rapid-i™ KitVitrolife Sweden AB · 2019 · cites it directly3descendants
- K200815VitriGuardOrigio A/S · 2020 · 2 generations on2descendants
- K241341cryo-GO Vitrification DeviceFujifilm Irvine Scientific · 2024 · 3 generations on0descendants
- K233177Nest VT Vitrification DeviceCook Incorporated · 2024 · 3 generations on0descendants
View 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) | K140207 | Rapid-I Kit | Vitrolife Sweden AB | 2014 | — |
| +1 | K181461 | Rapid-i™ Kit | Vitrolife Sweden AB | 2019 | — |
| +2 | K200815 | VitriGuard | Origio A/S | 2020 | — |
| +3 | K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 2024 | — |
| +3 | K233177 | Nest VT Vitrification Device | Cook Incorporated | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K090832 | Rapid-ISummary page 5…I Classification: Page 1 Predicate Vitrolife Rapid-i™ (K090832) Device: Indications for The Rapid-i™ Kit is a cryopreservation device designed to contain, vitrify and Use: main… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181461 | Rapid-i™ Kit | 2019 | 3 |
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 10 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181461 (Vitrolife Sweden AB, 2019) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K090832.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Rapid-i™ Kit is a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140207: Rapid-I Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140207
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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