# K043116: ICSI-100

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Jan 13, 2005 after 64 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 K991343 (1999). 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)
- K991343: PVP (Polyvinylpyrrolidone), Irvine Scientific Sales Co., Inc. (1999) Summary page 1.

## Indications for use
For the immobilization and isolation of sperm prior to intracytoplasmic sperm injection, ICSI.

Source page: https://510kreport.com/device/K043116
Methodology: https://510kreport.com/methodology