# K991342: PBS 1X- Dulbecco's Phosphate Buffered Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 8, 1999 after 80 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K160863: PBS (-), Phosphate Buffered Saline (2016), 0 descendants of its own

## Indications for use
Dulbecco’s Phosphate Buffered Saline Solution (PBS 1X) is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, PBS 1X is intended for use as a sperm-processing medium in washing procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo.

Source page: https://510kreport.com/device/K991342
Methodology: https://510kreport.com/methodology