# K980814: Puresperm

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Jun 23, 1998 after 112 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: 2 generations back to K872849 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971809: Isolate, Irvine Scientific Sales Co., Inc. (1997) Summary page 1.
- K894432: Modified Ham's F-10 W/Albumin, Irvine Scientific (1989) Summary page 1.
- K872849: Sperm-Select Additional Indication, Pharmacia, Inc. (1987) Summary page 1.

## Most influential descendants
- K984172: Modification of Puresperm (1999), 0 descendants of its own

## Indications for use
The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (TUI).

Source page: https://510kreport.com/device/K980814
Methodology: https://510kreport.com/methodology