# K991390: 1.5 M Propanediol Freezing Medium, 1.5 Propanediol 0.1 Sucrose Freezing Medium, 9% Glycerol, 0.2 M Sucrose Freezing Medi

- Pathway: 510(k) (Traditional)
- Applicant: Sage Biopharma
- Decided: Jan 18, 2000 after 272 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 2 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 25, 2016 · Class III · Z-2850-2016: Products contain international package insert and not the correct USA package insert
- Aug 25, 2016 · Class III · Z-2851-2016: Products contain international package insert and not the correct USA package insert

## Indications for use
Cryopreservation Media is used for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation. They are used during the cryopreservation process of preserving embryos, both for freezing and thawing during assisted reproduction procedures.

Source page: https://510kreport.com/device/K991390
Methodology: https://510kreport.com/methodology