# K122982: Cryolock

- Pathway: 510(k) (Traditional)
- Applicant: Biotech, Inc.
- Decided: Jan 9, 2014 after 470 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- 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 K041562 (2004). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 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.
- K090832: Rapid-I, Vitrolife Sweden AB (2009) Summary page 1.

## Most influential descendants
- K153027: Cryotop US (2016), 3 descendants of its own
- K181469: Cryotop®US-flash and Cryotop®US-scoop (2018), 1 descendant of its own
- K162640: iVitri EZ (2017), 1 descendant of its own
- K162833: VitriGuard (2017), 1 descendant of its own
- K241454: Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (2025), 0 descendants of its own

## Indications for use
The CRYOLOCK T5' is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos.

Source page: https://510kreport.com/device/K122982
Methodology: https://510kreport.com/methodology