# K991471: Medi-Cult Blastocyst Freezing & Thawing Packs, Internal Catalog Numbers (1012, 1015)

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: May 9, 2000 after 391 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
- K031486: Blastfreeze and Blastthaw (2003), 0 descendants of its own

## Indications for use
Blastocyst Freezing pack is for freezing of blastocysts in a two-step procedure. Blastocyst Thawing pack is for thawing of blastocysts in a two-step procedure.

Source page: https://510kreport.com/device/K991471
Methodology: https://510kreport.com/methodology