# K032086: Kryo Art Controlled Rate Freezer

- Pathway: 510(k) (Traditional)
- Applicant: Planer Plc
- Decided: Mar 19, 2004 after 256 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0211042: CryoMed IVF Controlled Rate Freezer. Number could not be read

## Most influential descendants
- K221086: CryoRobot Select System (2022), 0 descendants of its own

## Indications for use
The Kryo ART brand of cohtro1led rate freezers are intended to be used to freeze gametes or embryos at a user determined rate.

Source page: https://510kreport.com/device/K032086
Methodology: https://510kreport.com/methodology