510(k) · Cleared

Cleared

Rapidvit and Rapidwarm Cleave

K080446510(k) TraditionalCleared Nov 26, 2008281-day reviewClass II21 CFR 884.6180

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vitrolife Sweden AB · MQL Media, Reproductive

Cleared on Nov 26, 2008 as substantially equivalent to K060168 (Irvine Scientific Sales Co., Inc., 2006) after a 281-day review. Its family tree reaches back 1 generation to 2006. 21 later devices descend from it.

Decided: Nov 26, 2008
Review: 281 days
Class: Class II
Product code: MQL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K060168 (2006). 21 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK060168 Vitrification Freeze Kit, Vitrification Thaw KitIrvine Scientific Sales Co., Inc. · 2006
This deviceK080446 Rapidvit and Rapidwarm CleaveVitrolife Sweden AB · 2008
Descendant · cites it directly · 17 of its ownK093273 Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
Descendant · 2 generations on · 14 of its ownK160006 Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze…Irvine Scientific · 2016 · Recalled
Descendant · 3 generations on · 7 of its ownK171748 Vitrification Kit and Thawing KitKitazato Corporation · 2017
Descendant · 3 generations on · 2 of its ownK190152 Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019
Descendant · 4 generations on · 1 of its ownK251305 Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2010high 4 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 21 · See all

K093273Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010 · cites it directly17descendants
K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…Irvine Scientific · 2016 · 2 generations on14descendants
K171748Vitrification Kit and Thawing KitKitazato Corporation · 2017 · 3 generations on7descendants
K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019 · 3 generations on2descendants
K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K060168	Vitrification Freeze Kit, Vitrification Thaw Kit	Irvine Scientific Sales Co., Inc.	2006	—
0 (this device)	K080446	Rapidvit and Rapidwarm Cleave	Vitrolife Sweden AB	2008	—
+1	K093273	Vit Kit - Freeze and Thaw	Irvine Scientific Sales Co., Inc.	2010	—
+2	K160006	Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit…	Irvine Scientific	2016	2
+3	K171748	Vitrification Kit and Thawing Kit	Kitazato Corporation	2017	—
+3	K190152	Vit Kit- Freeze NX and Vit Kit- Warm NX	Fujifilm Irvine Scientific, Inc.	2019	—
+4	K251305	Ultra-Fast Vitri; Ultra-Fast Warm	Kitazato Corporation	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2016	2	0
2017	1	0
2018	2	0
2019	2	0
2023	1	0
2024	4	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K080446, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K060168	Vitrification Freeze Kit, Vitrification Thaw Kit Summary page 1 …(21 C.F.R. § 884.6180) Predicate Device: Vit KitTM - Freeze and Vit KitTM - Thaw from Irvine Scientific Co., Inc. (K060168) Description of the Device: RapidVit' Cleave is used for vitrification of day 3 cleava…	Irvine Scientific Sales Co., Inc.	2006	—

Also cleared against K060168: 6 other devices →

What descends from it? (21)

See all 21

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093273	Vit Kit - Freeze and Thaw	Irvine Scientific Sales Co., Inc.	2010	17
K101003	Rapidvit Blast, Rapidwarm Blast	Vitrolife Sweden AB	2010	1
K100367	Medicult Vitrification Cooling/Warming, Model Ref: 1228, 1229	Origio A/S	2010	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?

Its one ancestor has no recall.
Of its descendants, K093273 (Irvine Scientific Sales Co., Inc., 2010) has gone furthest, with 17 descendants of its own.
6 other devices also cite its predicate K060168.

How does its category compare?

All MQL devices

MQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MQL

9in 2025

2007high 12 (2008) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQL

225in 2025

2007high 316 (2022) · low 87 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQL

1in 2023

2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQL

3in 2025

2007high 6 (2024) · low 0 (2007)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 Cleave is indicated for vitrification of day 3 cleavage stage embryos

RapidWarm TM Cleave is indicated for warming of vitrified day 3 cleavage stage embryos

RapidVit TM Cleavage and RapidWarm Cleavage are restricted to sale by or on the order of a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080446 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080446: Rapidvit and Rapidwarm Cleave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080446

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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