# K092398: HSV Straw

- Pathway: 510(k) (Traditional)
- Applicant: Cryo Bio System
- Decided: Oct 6, 2010 after 426 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.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 2.
- K090832: Rapid-I, Vitrolife Sweden AB (2009). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K140072: Cryotop (R) SC (2014), 0 descendants of its own
- K112695: Cryotop (2012), 0 descendants of its own

## Indications for use
The HSV Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 Cell and blastocyst stage embryos.

Source page: https://510kreport.com/device/K092398
Methodology: https://510kreport.com/methodology