510(k) · Cleared

Recalled · Class II · 2021

Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit

K160006510(k) TraditionalCleared May 4, 2016121-day reviewClass II21 CFR 884.6180Recalls 2

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

Irvine Scientific · MQL Media, Reproductive

Cleared on May 4, 2016 as substantially equivalent to K093273 (Irvine Scientific Sales Co., Inc., 2010) after a 121-day review. Its family tree reaches back 4 generations to 2000. 14 later devices descend from it. It has been recalled 2 times.

Decided: May 4, 2016
Review: 121 days
Class: Class II
Product code: MQL
Recalls: 2
Predicates: 1

Its longest line of descent runs back 4 generations to K000309 (2000). 8 ancestors in all. 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK000309 Blastocyst Freeze Medium, Blastocyst Thaw MediumIrvine Scientific Sales Co., Inc. · 2000
3 generations backK032154 G-Freezekit BlastVitrolife AB · 2004
2 generations backK073522 Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 2008
1 generation backK093273 Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
This deviceK160006 Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze…Irvine Scientific · 2016
Descendant · cites it directly · 7 of its ownK171748 Vitrification Kit and Thawing KitKitazato Corporation · 2017
Descendant · cites it directly · 2 of its ownK190152 Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019
Descendant · 2 generations on · 1 of its ownK251305 Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025
Descendant · cites it directly · 1 of its ownK173731 SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification…CooperSurgical, Inc. · 2018
Descendant · 2 generations on · 0 of its ownK254261 Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)Cell Store (Beijing) Biotechnology CO., LTD. · 2026

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2017high 4 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 14 · See all

K171748Vitrification Kit and Thawing KitKitazato Corporation · 2017 · cites it directly7descendants
K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019 · cites it directly2descendants
K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation · 2025 · 2 generations on1descendant
K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit…CooperSurgical, Inc. · 2018 · cites it directly1descendant
K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)Cell Store (Beijing) Biotechnology CO., LTD. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000309	Blastocyst Freeze Medium, Blastocyst Thaw Medium	Irvine Scientific Sales Co., Inc.	2000	—
−3	K032154	G-Freezekit Blast	Vitrolife AB	2004	—
−2	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	—
0 (this device)	K160006	Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit…	Irvine Scientific	2016	—
+1	K171748	Vitrification Kit and Thawing Kit	Kitazato Corporation	2017	—
+1	K190152	Vit Kit- Freeze NX and Vit Kit- Warm NX	Fujifilm Irvine Scientific, Inc.	2019	—
+2	K251305	Ultra-Fast Vitri; Ultra-Fast Warm	Kitazato Corporation	2025	—
+1	K173731	SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming…	CooperSurgical, Inc.	2018	—
+2	K254261	Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)	Cell Store (Beijing) Biotechnology CO., LTD.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0
2006	1	0
2008	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K160006, 2000–2026Source: 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
*	K093273	Vit Kit - Freeze and Thaw Summary page 5 …84.6180 Device Classification: Class II Product Code: MQL Predicate Device: Vit Kit® - Freeze, Irvine Scientific (K093273) Vit Kit® - Thaw, Irvine Scientific (K093273)…	Irvine Scientific Sales Co., Inc.	2010	—

Also cleared against K093273: 1 other device →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K171748	Vitrification Kit and Thawing Kit	Kitazato Corporation	2017	7
K190152	Vit Kit- Freeze NX and Vit Kit- Warm NX	Fujifilm Irvine Scientific, Inc.	2019	2
K173731	SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit…	CooperSurgical, Inc.	2018	1
K183486	RapidVit™ Oocyte, RapidWarm™ Oocyte	Vitrolife Sweden AB	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 8, 2021	Class II	Z-0248-2022	Software design	Due to a component in kit being labeled with the incorrect Expiration Date
Sep 8, 2021	Class II	Z-0249-2022	Software design	Due to a component in kit being labeled with the incorrect Expiration Date

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K171748 (Kitazato Corporation, 2017) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K093273.

How does its category compare?

All MQL devices

MQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

Vit Kit® - Freeze (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit® - Thaw (Vitrification Thaw Kit) is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes 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/K160006

Report an extraction error

Are you the manufacturer?

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