# K160863: PBS (-), Phosphate Buffered Saline

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Biopharma Co., Ltd.
- Decided: Jul 28, 2016 after 121 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 K991342 (1999). 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)
- K991342: PBS 1X- Dulbecco's Phosphate Buffered Saline Solution, Irvine Scientific Sales Co., Inc. (1999) Summary page 4.

## Indications for use
PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.

Source page: https://510kreport.com/device/K160863
Methodology: https://510kreport.com/methodology