510(k) · Cleared

Cleared

Vitrification Freeze Kit, Vitrification Thaw Kit

K060168510(k) TraditionalCleared Apr 24, 200691-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

Irvine Scientific Sales Co., Inc. · MQL Media, Reproductive

Cleared on Apr 24, 2006 after a 91-day review. The FDA summary names no predicate by number. 30 later devices descend from it.

Decided: Apr 24, 2006
Review: 91 days
Class: Class II
Product code: MQL
Recalls: None
Predicates: 0

30 later devices descend from it, 7 citing it directly.

This deviceK060168 Vitrification Freeze Kit, Vitrification Thaw KitIrvine Scientific Sales Co., Inc. · 2006
Descendant · cites it directly · 21 of its ownK080446 Rapidvit and Rapidwarm CleaveVitrolife Sweden AB · 2008
Descendant · cites it directly · 19 of its ownK073522 Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 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

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2007high 4 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 30 · See all

K080446Rapidvit and Rapidwarm CleaveVitrolife Sweden AB · 2008 · cites it directly21descendants
K073522Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 2008 · cites it directly19descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K060168	Vitrification Freeze Kit, Vitrification Thaw Kit	Irvine Scientific Sales Co., Inc.	2006	—
+1	K080446	Rapidvit and Rapidwarm Cleave	Vitrolife Sweden AB	2008	—
+1	K073522	Vitrification Kit & Vitrification Warming Kit	Sage In-Vitro Fertilization, Inc.	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2009	1	0
2010	4	0
2015	1	0
2016	2	0
2017	4	0
2018	2	0
2019	2	0
2023	1	0
2024	4	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K060168, 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?

The FDA summary names no predicate by number.

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K080446	Rapidvit and Rapidwarm Cleave	Vitrolife Sweden AB	2008	21
K073522	Vitrification Kit & Vitrification Warming Kit	Sage In-Vitro Fertilization, Inc.	2008	19
K093273	Vit Kit - Freeze and Thaw	Irvine Scientific Sales Co., Inc.	2010	17
K082363	Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000) Kits	William A. Cook Australia Pty., Ltd.	2009	3
K101003	Rapidvit Blast, Rapidwarm Blast	Vitrolife Sweden AB	2010	1
K070135	Vitrifreeze Medium; Vitrithaw Medium	Fertipro NV	2007	1
K092107	Vitriblast, Thermoblast, Model VB-010, TB-010	Nidacon International AB	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?

Of its descendants, K080446 (Vitrolife Sweden AB, 2008) has gone furthest, with 21 descendants of its own.

How does its category compare?

All MQL devices

MQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Vit Kit - Freeze is intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Irvine Scientific's Blastocyst Vitrification Thaw Kit (Vit Kit - Thaw, Catalog #90137) for optimal recovery of specimens.

Vit Kit - Thaw is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Irvine Scientific's Blastocyst Vitrification Freeze Kit (Vit Kit - Freeze, Catalog #90133) for Assisted Reproductive Technology (A.R.T.) procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060168: Vitrification Freeze Kit, Vitrification Thaw Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060168

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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