# K021896: Hsa-Solution, Model 10034/10064

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Sep 6, 2002 after 88 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K098354: Human Serum Albumin. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
HSA-solution contains Human Serum Albumin solution (100 mg/mL) and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of HSA-solution as a supplement for culture medium. Not for use as an injectable product.

Source page: https://510kreport.com/device/K021896
Methodology: https://510kreport.com/methodology