# K991391: PVP, Polyvinylpyrrolidone 10% (W/V) in Hepes-HTF

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Reproductive Technologies
- Decided: Jan 10, 2000 after 264 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K011607: Spermcatch (2001), 1 descendant of its own
- K052457: Picsi Sperm Selection Device (2006), 0 descendants of its own

## Indications for use
PVP is used for the intracytoplasmic sperm injection (ICSl) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.

Source page: https://510kreport.com/device/K991391
Methodology: https://510kreport.com/methodology