# K233764: SSS-NX (Serum Substitute Supplement-NX)

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Irvine Scientific
- Decided: Apr 24, 2024 after 152 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 K983579 (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)
- K983579: Synthetic Serum Substitute (SSS), Irvine Scientific Sales Co., Inc. (1999) Summary page 5.

## Indications for use
SSS-NX is intended for use in assisted reproductive technology (ART) procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for ART media.

Source page: https://510kreport.com/device/K233764
Methodology: https://510kreport.com/methodology