# K983580: Blastocyst 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 its predicate without a number.
- (no number) Notice of Final Rule, 63 FR 48428, Docket number 97N-0335: named in the summary without a submission number

## Indications for use
Blastocyst Medium is intended for use in assisted reproductive technology procedures that include gamete and embryo manipulation. Specifically, Blastoycst is intended for use as an in vitro culture medium from day three through day five of embryo development.

Source page: https://510kreport.com/device/K983580
Methodology: https://510kreport.com/methodology