# K991348: Ivf 20, Ivf 50, Ivf 500, Ivf 500 Antibiotic Free, Models 2420, 2004, 2501, 2500

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: May 17, 2000 after 394 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Reproductive Media (category): named in the summary without a submission number

## Indications for use
For in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.

Source page: https://510kreport.com/device/K991348
Methodology: https://510kreport.com/methodology