# K991392: Human Serum Albumin

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Reproductive Technologies
- Decided: Feb 7, 2000 after 292 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT,- ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for [Ul].

Source page: https://510kreport.com/device/K991392
Methodology: https://510kreport.com/methodology