# K991339: Tyrode's Solution-Acidified

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Dec 6, 1999 after 231 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
Tyrode's Solution, Acidified is intended for use in assisted reproductive procedures involving the manipulation of embryos. Specifically, Tyrode’s Solution, Acidified, is intended for use in zona-drilling procedures.

Source page: https://510kreport.com/device/K991339
Methodology: https://510kreport.com/methodology