# K092107: Vitriblast, Thermoblast, Model VB-010, TB-010

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Jun 15, 2010 after 336 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
Longest line of descent: 2 generations back to K060168 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060168: Vitrification Freeze Kit, Vitrification Thaw Kit, Irvine Scientific Sales Co., Inc. (2006) Summary page 2.
- K070135: Vitrifreeze Medium; Vitrithaw Medium, Fertipro NV (2007) Summary page 2.

## Indications for use
VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast Thaw Kit for optimal recovery of specimens. This product is used for Assisted Reproductive Technology (ART.) procedures. ThermoBlast is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing using Nidacon's VitriBlast Kit. It is designed for optimal recovery of specimens. This product is used for Assisted Reproductive Technology (A.R.T.) procedures.

Source page: https://510kreport.com/device/K092107
Methodology: https://510kreport.com/methodology