# K153027: Cryotop US

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Biopharma Co., Ltd.
- Decided: Mar 14, 2016 after 150 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.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122982: Cryolock, Biotech, Inc. (2014) Summary page 5.

## Most influential descendants
- K181469: Cryotop®US-flash and Cryotop®US-scoop (2018), 1 descendant of its own
- K241454: Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (2025), 0 descendants of its own
- K162051: Cryotec (2016), 0 descendants of its own

## Indications for use
The Cryotop®US 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/K153027
Methodology: https://510kreport.com/methodology