510(k) · Cleared
ClearedRapidvit Blast, Rapidwarm Blast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife Sweden AB · MQL Media, Reproductive
Cleared on Dec 10, 2010 as substantially equivalent to K080446 (Vitrolife Sweden AB, 2008) and 1 other predicate after a 242-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Dec 10, 2010
- Review
- 242 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K060168 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK060168 Vitrification Freeze Kit, Vitrification Thaw KitIrvine Scientific Sales Co., Inc. · 2006
- 1 generation backK080446 Rapidvit and Rapidwarm CleaveVitrolife Sweden AB · 2008
- This deviceK101003 Rapidvit Blast, Rapidwarm BlastVitrolife Sweden AB · 2010
- Descendant · cites it directly · 0 of its ownK240605 Ultra RapidWarm™ BlastVitrolife Sweden AB · 2024
Most influential descendants
Showing 1 of 1 · See all- K240605Ultra RapidWarm™ BlastVitrolife Sweden AB · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060168 | Vitrification Freeze Kit, Vitrification Thaw Kit | Irvine Scientific Sales Co., Inc. | 2006 | — |
| −1 | K080446 | Rapidvit and Rapidwarm Cleave | Vitrolife Sweden AB | 2008 | — |
| 0 (this device) | K101003 | Rapidvit Blast, Rapidwarm Blast | Vitrolife Sweden AB | 2010 | — |
| +1 | K240605 | Ultra RapidWarm™ Blast | Vitrolife Sweden AB | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 MQL? 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 MQL device
- #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 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 |
|---|---|---|---|
| * | K080446 | Rapidvit and Rapidwarm CleaveSummary page 1…(21 C.F.R. § 884.6180) Predicate Devices: RapidVit TM Cleave and Rapid WarMTM Cleave (K080446) from Vitrolife, and Vit KitTM - Freeze and Vit KitTM - Thaw from Irvine… | 2008 |
| * | K060168 | Vitrification Freeze Kit, Vitrification Thaw KitSummary page 1…080446) from Vitrolife, and Vit KitTM - Freeze and Vit KitTM - Thaw from Irvine Scientific Co., Inc. (K060 168) Description of the Device: RapidVit TM Blast and Rapid WarMm Blast is a device used fo… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240605 | Ultra RapidWarm™ Blast | 2024 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240605 (Vitrolife Sweden AB, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K080446.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQL
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQL
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQL
3in 2025
MAUDE reports naming product code MQL, 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 | 3 | 212 | 0 | 0 |
| 2008 | 12 | 151 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 235 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 253 | 1 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 5 | 142 | 0 | 3 |
| 2015 | 7 | 87 | 0 | 0 |
| 2016 | 12 | 170 | 0 | 2 |
| 2017 | 10 | 113 | 0 | 0 |
| 2018 | 4 | 94 | 0 | 0 |
| 2019 | 6 | 170 | 0 | 0 |
| 2020 | 8 | 257 | 1 | 0 |
| 2021 | 1 | — | 2 | 0 |
| 2022 | 3 | 316 | 1 | 0 |
| 2023 | 5 | 199 | 1 | 1 |
| 2024 | 12 | 195 | 0 | 6 |
| 2025 | 9 | 225 | 0 | 3 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
RapidVit Tm Blast is indicated for vitrification of human blastocyst stage embryos
RapidWarm Tm Blast is indicated for warming of vitrified human blastocyst stage embryos
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101003: Rapidvit Blast, Rapidwarm Blast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101003
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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