# K991378: Phosphate Buffered Saline (PBS), Phosphate Buffered Saline with Calcium, Magnesium, Glucose, Pyruvate and Phenol Red

- Pathway: 510(k) (Traditional)
- Applicant: Sage Biopharma
- 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
Phosphate Buffered Saline (PBS) and Phosphate Buffered Saline, with calcium, magnesium, glucose, pyruvate and phenol red are for in vitro procedures involving the manipulations of gametes and embryos such as oocyte retrieval or embryo transfer, gamete washing, or micromanipulation. They may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservation agent(s).

Source page: https://510kreport.com/device/K991378
Methodology: https://510kreport.com/methodology