510(k) · Cleared
ClearedRapid-I
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 23, 2009 as substantially equivalent to K041562 (Irvine Scientific Sales Co., Inc., 2004) after a 272-day review. Its family tree reaches back 1 generation to 2004. 17 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 272 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041562 (2004). 17 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- This deviceK090832 Rapid-IVitrolife Sweden AB · 2009
- Descendant · cites it directly · 8 of its ownK122982 CryolockBiotech, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK140207 Rapid-I KitVitrolife Sweden AB · 2014
- Descendant · 2 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
- Descendant · 3 generations on · 2 of its ownK200815 VitriGuardOrigio A/S · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K122982CryolockBiotech, Inc. · 2014 · cites it directly8descendants
- K140207Rapid-I KitVitrolife Sweden AB · 2014 · cites it directly4descendants
- K181461Rapid-i™ KitVitrolife Sweden AB · 2019 · 2 generations on3descendants
- K153027Cryotop USKitazato Biopharma Co., Ltd. · 2016 · 2 generations on3descendants
- K200815VitriGuardOrigio A/S · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041562 | Cryotip | Irvine Scientific Sales Co., Inc. | 2004 | — |
| 0 (this device) | K090832 | Rapid-I | Vitrolife Sweden AB | 2009 | — |
| +1 | K122982 | Cryolock | Biotech, Inc. | 2014 | — |
| +1 | K140207 | Rapid-I Kit | Vitrolife Sweden AB | 2014 | — |
| +2 | K181461 | Rapid-i™ Kit | Vitrolife Sweden AB | 2019 | — |
| +2 | K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016 | — |
| +3 | K200815 | VitriGuard | Origio A/S | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 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 |
|---|---|---|---|
| * | K041562 | CryotipSummary page 1…on Name: Assisted Reproduction Labware (21 C.F.R. § 884.6160) Product Code: MQK Predicate Device: CryoTip TM (1(041562) Description of the Device: Rapid-iTM is a modification of the CiyoTi pT m microtool from Irvine Scientific Sales… | 2004 |
What descends from it? (17)
See all 173 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?
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Rapid-iTM is a cryopreservation device indicated to be used to contain, vitrify and maintain 4-8 cell stage embryos
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090832: Rapid-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090832
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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