# K983589: P-1 (Preimplantation Stage One) Medium

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Feb 18, 1999 after 128 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. The FDA summary names no predicate by number.

## Indications for use
P-1® medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, P-1® is intended for use as a culture medium through day three of embryo development.

Source page: https://510kreport.com/device/K983589
Methodology: https://510kreport.com/methodology