# K031304: Sydney Ivf PVP

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 23, 2004 after 334 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 63 FR 48428, September 10, 1998: named in the summary without a submission number

## Most influential descendants
- K152440: Sydney IVF PVP (2015), 0 descendants of its own

## Indications for use
Sydney IVFTM PVP consists of a sperm medium containing 10% Polyvinylpyrrolidone (PVP) and is intended for use as an aid in the immobilization and isolation of indivudal sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Source page: https://510kreport.com/device/K031304
Methodology: https://510kreport.com/methodology