# K181469: Cryotop®US-flash and Cryotop®US-scoop

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Nov 9, 2018 after 158 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: 4 generations back to K041562 (2004). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153027: Cryotop US, Kitazato Biopharma Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K241454: Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (2025), 0 descendants of its own

## Indications for use
Cryotop®US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.

Source page: https://510kreport.com/device/K181469
Methodology: https://510kreport.com/methodology