# K073522: Vitrification Kit & Vitrification Warming Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sage In-Vitro Fertilization, Inc.
- Decided: Oct 10, 2008 after 301 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 K000309 (2000). 4 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 24 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.
- K032154: G-Freezekit Blast, Vitrolife AB (2004) Summary page 2.
- K032155: G-Thawkit Blast, Vitrolife AB (2004) Summary page 2.

## Most influential descendants
- K093273: Vit Kit - Freeze and Thaw (2010), 17 descendants of its own
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (2016), 14 descendants of its own
- K171748: Vitrification Kit and Thawing Kit (2017), 7 descendants of its own
- K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX (2019), 2 descendants of its own
- K251305: Ultra-Fast Vitri; Ultra-Fast Warm (2025), 1 descendant of its own

## Indications for use
Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens. Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.

Source page: https://510kreport.com/device/K073522
Methodology: https://510kreport.com/methodology