510(k) · Cleared

Cleared

G-Thawkit Blast

K032155510(k) TraditionalCleared May 7, 2004298-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 AB · MQL Media, Reproductive

Cleared on May 7, 2004 as substantially equivalent to K000309 (Irvine Scientific Sales Co., Inc., 2000) after a 298-day review. Its family tree reaches back 1 generation to 2000. 20 later devices descend from it.

Decided: May 7, 2004
Review: 298 days
Class: Class II
Product code: MQL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000309 (2000). 20 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK000309 Blastocyst Freeze Medium, Blastocyst Thaw MediumIrvine Scientific Sales Co., Inc. · 2000
This deviceK032155 G-Thawkit BlastVitrolife AB · 2004
Descendant · cites it directly · 19 of its ownK073522 Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 2008
Descendant · 2 generations on · 17 of its ownK093273 Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
Descendant · 3 generations on · 14 of its ownK160006 Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze…Irvine Scientific · 2016 · Recalled
Descendant · 4 generations on · 7 of its ownK171748 Vitrification Kit and Thawing KitKitazato Corporation · 2017
Descendant · 4 generations on · 2 of its ownK190152 Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2008high 4 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 20 · See all

K073522Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc. · 2008 · cites it directly19descendants
K093273Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010 · 2 generations on17descendants
K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…Irvine Scientific · 2016 · 3 generations on14descendants
K171748Vitrification Kit and Thawing KitKitazato Corporation · 2017 · 4 generations on7descendants
K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000309	Blastocyst Freeze Medium, Blastocyst Thaw Medium	Irvine Scientific Sales Co., Inc.	2000	—
0 (this device)	K032155	G-Thawkit Blast	Vitrolife AB	2004	—
+1	K073522	Vitrification Kit & Vitrification Warming Kit	Sage In-Vitro Fertilization, Inc.	2008	—
+2	K093273	Vit Kit - Freeze and Thaw	Irvine Scientific Sales Co., Inc.	2010	—
+3	K160006	Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit…	Irvine Scientific	2016	2
+4	K171748	Vitrification Kit and Thawing Kit	Kitazato Corporation	2017	—
+4	K190152	Vit Kit- Freeze NX and Vit Kit- Warm NX	Fujifilm Irvine Scientific, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2016	2	0
2017	2	0
2018	2	0
2019	2	0
2023	1	0
2024	3	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K032155, 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
*	K000309	Blastocyst Freeze Medium, Blastocyst Thaw Medium Summary page 1 …Reproductive Media and Supplements (21 C.F.RI § 884.6180) Predicate Device: Blastocyst Thaw Media Kit (K000309) Description of the Device: MOPS buffered media. For use in sequence after…	Irvine Scientific Sales Co., Inc.	2000	—

Also cleared against K000309: 1 other device →

What descends from it? (20)

See all 20

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073522	Vitrification Kit & Vitrification Warming Kit	Sage In-Vitro Fertilization, Inc.	2008	19

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, K073522 (Sage In-Vitro Fertilization, Inc., 2008) has gone furthest, with 19 descendants of its own.
1 other device also cites its predicate K000309.

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?

Media for thawing of blastocyst stage embryos

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032155 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032155: G-Thawkit Blast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032155

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