# K152440: Sydney IVF PVP

- Pathway: 510(k) (Special)
- Applicant: Willam A. Cook Australia Pty, Ltd.
- Decided: Sep 23, 2015 after 27 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 K031304 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031304: Sydney Ivf PVP, Cook Urological, Inc. (2004) Summary page 4.

## Indications for use
Sydney IVF PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Source page: https://510kreport.com/device/K152440
Methodology: https://510kreport.com/methodology