# K140072: Cryotop (R) SC

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Biopharma Co., Ltd.
- Decided: Apr 3, 2014 after 80 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K041562 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092398: HSV Straw, Cryo Bio System (2010) Summary page 1.

## Indications for use
The Cryotop®SC is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

Source page: https://510kreport.com/device/K140072
Methodology: https://510kreport.com/methodology