510(k) Report

510(k) · Cleared

Cleared

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium

K153290510(k) SpecialCleared Jan 27, 201675-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

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

Cleared on Jan 27, 2016 as substantially equivalent to K002385 (Cook Ob/Gyn, 2000) after a 75-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.

Decided
Jan 27, 2016
Review
75 days
Class
Class II
Product code
MQL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002385 (2000). 6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2022: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant clearedK002385 · Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium, · Cook Ob/Gyn · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 1 descendant K002385 · Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium, · Cook Ob/Gyn · 20000
  1. Root · 1 generation backK002385 Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook…Cook Ob/Gyn · 2000
  2. This deviceK153290 Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium…William A. Cook Australia Pty., Ltd. · 2016
  3. Descendant · cites it directly · 1 of its ownK200408 VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium…Shenzhen Vitavitro Biotech Co., Ltd. · 2020
  4. Descendant · 2 generations on · 0 of its ownK251637 Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025
  5. Descendant · cites it directly · 0 of its ownK231370 Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd. · 2023
  6. Descendant · cites it directly · 0 of its ownK212426 Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2022
  7. Descendant · cites it directly · 0 of its ownK200249 Sequential Culture Media (Fertilization Medium [without HSA/rHA…Kitazato Corporation · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12020: 22022: 12023: 12025: 1
2017high 2 (2020) · low 0 (2018)2026

Most influential descendants

Showing 5 of 6 · See all
  • K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…Shenzhen Vitavitro Biotech Co., Ltd. · 2020 · cites it directly1descendant
  • K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025 · 2 generations on0descendants
  • K231370Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd. · 2023 · cites it directly0descendants
  • K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2022 · cites it directly0descendants
  • K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA]…Kitazato Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002385Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf…Cook Ob/Gyn2000—
0 (this device)K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF…William A. Cook Australia Pty., Ltd.2016—
+1K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro®…Shenzhen Vitavitro Biotech Co., Ltd.2020—
+2K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]…Donnevie Medical Technology (Shanghai) Co., Ltd.2025—
+1K231370Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd.2023—
+1K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without…Donnevie Medical Technology (Shanghai) Co., Ltd.2022—
+1K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA…Kitazato Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202020
202210
202310
202510
FIG. 1 — Lineage of K153290, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K002385Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…
Summary page 4
…PREDICATE DEVICE: Cook IVF Follicle Flushing Buffer, Cook IVF Oocyte Wash Buffer, Cook IVF Fertilization Medium, Cook IVF Cleavage Medium and Cook IVF Blastocyst Medium (K002385), cleared September 18, 2000. DEVICE DESCRIPTION: The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney…
Cook Ob/Gyn2000—

Also cleared against K002385: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…Shenzhen Vitavitro Biotech Co., Ltd.20201
K231370Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd.20230
K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and…Donnevie Medical Technology (Shanghai) Co., Ltd.20220
K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA]…Kitazato Corporation20200
K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…Genea Biomedx Pty, Ltd.20170

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, K200408 (Shenzhen Vitavitro Biotech Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K002385.

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

2007: 32008: 122009: 22010: 62011: 12012: 52014: 52015: 72016: 122017: 102018: 42019: 62020: 82021: 12022: 32023: 52024: 122025: 92026 (partial year): 3
2007high 12 (2008) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQL

225in 2025

2007: 212 days median2008: 151 days median2010: 235 days median2012: 253 days median2014: 142 days median2015: 87 days median2016: 170 days median2017: 113 days median2018: 94 days median2019: 170 days median2020: 257 days median2022: 316 days median2023: 199 days median2024: 195 days median2025: 225 days median2026 (partial year): 179 days median
2007high 316 (2022) · low 87 (2015)2026

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

Recalls per year · MQL

1in 2023

2012: 12020: 12021: 22022: 12023: 1
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

2012: 12013: 22014: 32016: 22023: 12024: 62025: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007321200
20081215100
20092—00
2010623500
20111—00
2012525311
20130—02
2014514203
201578700
20161217002
20171011300
201849400
2019617000
2020825710
20211—20
2022331610
2023519911
20241219506
2025922503
202631790—

What is it indicated for?

Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection.

Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination and incubation of oocytes.

Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos.

Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.

Indications for use as stated in the FDA summary.

Also cleared against K002385

2 other devices cite the same predicate.

  • K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50Genea Biomedx Pty, Ltd. · 2017
  • K133912Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav, Origio Sequential…Origio A/S · 2014

More from William A. Cook Australia Pty., Ltd.

14 FDA decisions under this applicant name. See the company

  • K173431Towako Transmyometrial Embryo Transfer SetWilliam A. Cook Australia Pty., Ltd. · 2018
  • K171611Double Lumen Ovum Aspiration NeedlesWilliam A. Cook Australia Pty., Ltd. · 2017
  • K160753COOK Vacuum PumpWilliam A. Cook Australia Pty., Ltd. · 20171 recall
  • K170257Sydney IVF Culture OilWilliam A. Cook Australia Pty., Ltd. · 2017
  • K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty., Ltd. · 2016

Recent decisions in MQL

The MQL category page

  • K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)Cell Store (Beijing) Biotechnology CO., LTD. · 2026
  • K260248Ultra-Fast WarmKitazato Corporation · 2026
  • K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc. · 2026
  • K250445Fast Warm - NXFujifilm Irvine Scientific · 2025
  • K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025

https://510kreport.com/device/K153290 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153290: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153290

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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