510(k) · Cleared

Cleared

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

K152682510(k) SpecialCleared May 5, 2016230-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

Willian A. Cook Australia Pty, Ltd. · MQL Media, Reproductive

Cleared on May 5, 2016 as substantially equivalent to K011157 (Cook Urological, Inc., 2001) after a 230-day review. Its family tree reaches back 1 generation to 2001.

Decided: May 5, 2016
Review: 230 days
Class: Class II
Product code: MQL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011157 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK011157 Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw KitCook Urological, Inc. · 2001
This deviceK152682 Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011157	Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit	Cook Urological, Inc.	2001	—
0 (this device)	K152682	Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit	Willian A. Cook Australia Pty, Ltd.	2016	—

FIG. 1 — Lineage of K152682, 2001–2016Source: 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

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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
*	K011157	Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit Summary page 5 …dia & Supplements Regulatory Class: II Product Code: MQL - Media, Reproductive PREDICATE DEVICE: Cook IVF Cryopreservation Kit & Cook IVF Thaw Kit (K011157), cleared May 3, 2001. DEVICE DESCRIPTION: The Sydney IVF Cryopreservation and Thawing Kits are intended for cryopreservation a…	Cook Urological, Inc.	2001	—

Also cleared against K011157: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
2 other devices also cite its predicate K011157.

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?

Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos.

Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152682: Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152682

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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