510(k) Report

510(k) · Cleared

Cleared

Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium,

K002385510(k) TraditionalCleared Sep 18, 200045-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

Cook Ob/Gyn · MQL Media, Reproductive

Cleared on Sep 18, 2000 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Sep 18, 2000
Review
45 days
Class
Class II
Product code
MQL
Recalls
None
Predicates
0

9 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2022: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK002385 Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook…Cook Ob/Gyn · 2000
  2. Descendant · cites it directly · 6 of its ownK153290 Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium…William A. Cook Australia Pty., Ltd. · 2016
  3. Descendant · 2 generations on · 1 of its ownK200408 VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium…Shenzhen Vitavitro Biotech Co., Ltd. · 2020
  4. Descendant · 3 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 · 2 generations on · 0 of its ownK231370 Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd. · 2023
  6. Descendant · 2 generations on · 0 of its ownK212426 Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 12016: 12017: 22020: 22022: 12023: 12025: 1
2014high 2 (2017) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…William A. Cook Australia Pty., Ltd. · 2016 · cites it directly6descendants
  • K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…Shenzhen Vitavitro Biotech Co., Ltd. · 2020 · 2 generations on1descendant
  • K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025 · 3 generations on0descendants
  • K231370Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd. · 2023 · 2 generations on0descendants
  • K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002385Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf…Cook Ob/Gyn2000—
+1K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF…William A. Cook Australia Pty., Ltd.2016—
+2K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro®…Shenzhen Vitavitro Biotech Co., Ltd.2020—
+3K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]…Donnevie Medical Technology (Shanghai) Co., Ltd.2025—
+2K231370Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd.2023—
+2K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without…Donnevie Medical Technology (Shanghai) Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201610
201720
202020
202210
202310
202510
FIG. 1 — Lineage of K002385, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…William A. Cook Australia Pty., Ltd.20166
K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50Genea Biomedx Pty, Ltd.20170
K133912Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav…Origio A/S20140

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, K153290 (William A. Cook Australia Pty., Ltd., 2016) has gone furthest, with 6 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

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—

More from Cook Ob/Gyn

43 FDA decisions under this applicant name. See the company

  • K062438Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
  • K030441Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitCook Ob/Gyn · 2003
  • K023850Sydney Ivf Embryo Biopsy MediumCook Ob/Gyn · 2003
  • K013597Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
  • K002383Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitCook Ob/Gyn · 2000

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/K002385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002385: Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002385

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026