# K221810: LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

- Pathway: 510(k) (Traditional)
- Applicant: Bonraybio Co., Ltd.
- Decided: Oct 31, 2022 after 131 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: 5 generations back to K990941 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173075: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml), Dxnow, Inc. (2018) Summary page 4.

## Indications for use
The LensHooke CAO Sperm Separation Device and the LensHooke CAI Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

Source page: https://510kreport.com/device/K221810
Methodology: https://510kreport.com/methodology