# K020490: PBS, PBSW with Cations and Phenol Red

- Pathway: 510(k) (Traditional)
- Applicant: Conception Technologies
- Decided: Mar 28, 2002 after 43 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
Phosphate Buffered Saline With Cations and Phenol Red (PBSW) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s). Phosphate Buffered Saline (PBS) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

Source page: https://510kreport.com/device/K020490
Methodology: https://510kreport.com/methodology