# K041562: Cryotip

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Aug 9, 2004 after 60 days
- Product code: MQH (Microtools, Assisted Reproduction (Pipettes))
- Device class: 2
- Regulation: 21 CFR 884.6130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K090832: Rapid-I (2009), 17 descendants of its own
- K122982: Cryolock (2014), 8 descendants of its own
- K140207: Rapid-I Kit (2014), 4 descendants of its own
- K181461: Rapid-i™ Kit (2019), 3 descendants of its own
- K153027: Cryotop US (2016), 3 descendants of its own

## Indications for use
The CryoTip is a cryopreservation device that is intended to be used to contain, freeze and maintain oocytes and/or embryos.

Source page: https://510kreport.com/device/K041562
Methodology: https://510kreport.com/methodology