# K100596: Cryopette

- Pathway: 510(k) (Traditional)
- Applicant: Mid-Atlantic Diagnostics, Inc.
- Decided: Dec 6, 2010 after 279 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041562 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041562: Cryotip, Irvine Scientific Sales Co., Inc. (2004) Summary page 1.

## Recalls of this device
- Nov 28, 2011 · Not classified · Z-1094-2012: Cryopettes were rupturing during the warming process following vitrification.

## Indications for use
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

Source page: https://510kreport.com/device/K100596
Methodology: https://510kreport.com/methodology