# K011606: Puresperm Buffer

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Jul 12, 2001 after 49 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: 1 generation back to K000621 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000621: Scandinavian Ivf Sciences AB, Spermrinse -20/100, Vitrolife AB/Scandinavian Ivf Sciences AB (2000) Summary page 1.

## Indications for use
The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.

Source page: https://510kreport.com/device/K011606
Methodology: https://510kreport.com/methodology