# K153290: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium

- Pathway: 510(k) (Special)
- Applicant: William A. Cook Australia Pty., Ltd.
- Decided: Jan 27, 2016 after 75 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002385 (2000). 1 ancestor in all.
6 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002385: Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium,, Cook Ob/Gyn (2000) Summary page 4.

## Most influential descendants
- K200408: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (2020), 1 descendant of its own
- K251637: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (2025), 0 descendants of its own
- K231370: Dewin Blastocyst Medium (with HSA and without HSA) (2023), 0 descendants of its own
- K212426: Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) (2022), 0 descendants of its own
- K200249: Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K153290
Methodology: https://510kreport.com/methodology