# K983579: Synthetic Serum Substitute (SSS)

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Apr 23, 1999 after 192 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K233764: SSS-NX (Serum Substitute Supplement-NX) (2024), 0 descendants of its own

## Indications for use
Serum Substitute Supplement (SSS) is designed for those assisted reproductive pracedures that require the use of a protein supplement. In particular, SSS is intended for use during in vitro fertilization, during in vitro embryo cuiture to the desired stage of embryo development, and for the cryopreservation of human embryos.

Source page: https://510kreport.com/device/K983579
Methodology: https://510kreport.com/methodology