# K991343: PVP (Polyvinylpyrrolidone)

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 14, 1999 after 86 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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 no predicate by number.

## Most influential descendants
- K011607: Spermcatch (2001), 1 descendant of its own
- K052457: Picsi Sperm Selection Device (2006), 0 descendants of its own
- K043116: ICSI-100 (2005), 0 descendants of its own

## Indications for use
PVP (polyvinylpyrrolidone) is intended for use in assisted reproductive technology procedures involving the manipulation of gametes. Specifically, PVP is intended for use as a medium for the immobilization of sperm during intracytoplasmic sperm injection (ICSI) procedures.

Source page: https://510kreport.com/device/K991343
Methodology: https://510kreport.com/methodology