# K991381: Pureception Lower Phase, Pureception Upper Phase, Pureception with Hepes-Buffered Ham's F-10 and Hsa

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Andrology, Inc.
- Decided: Sep 24, 1999 after 156 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
PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.

Source page: https://510kreport.com/device/K991381
Methodology: https://510kreport.com/methodology