# K170560: SAGE Vitrification Kit and SAGE Vitrification Warming Kit

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: Apr 4, 2017 after 36 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: 3 generations back to K000309 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073522: Vitrification Kit & Vitrification Warming Kit, Sage In-Vitro Fertilization, Inc. (2008) Summary page 4.

## Indications for use
SAGE Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts in assisted reproductive technology procedures. This kit is designed to be used in conjunction with the SAGE Vitrification Warming Kit (ART-8031) for optimal recovery of specimens. SAGE Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using SAGE Vitrification Kit (ART-8026) for assisted reproductive technology procedures.

Source page: https://510kreport.com/device/K170560
Methodology: https://510kreport.com/methodology