# K984172: Modification of Puresperm

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Jan 14, 1999 after 55 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: 3 generations back to K872849 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980814: Puresperm, Nidacon International AB (1998) Summary page 1.

## Indications for use
The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).

Source page: https://510kreport.com/device/K984172
Methodology: https://510kreport.com/methodology