# K232125: V-PVP

- Pathway: 510(k) (Traditional)
- Applicant: Vitromed GmbH
- Decided: Mar 20, 2024 after 247 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 K001967 (2000). 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)
- K001967: PVP-Polyvinylpyrrolidone Reagent, Model Cat#2210, Invitrocare, Inc. (2000) Summary page 5.

## Indications for use
V-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/K232125
Methodology: https://510kreport.com/methodology