# K052457: Picsi Sperm Selection Device

- Pathway: 510(k) (Traditional)
- Applicant: Biocoat, Inc.
- Decided: Apr 13, 2006 after 218 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 K991343 (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)
- K011607: Spermcatch, Nidacon International AB (2001) Summary page 1.
- K991253: Falcon Ivf Round Dish, Becton Dickinson Labware (1999) Summary page 1.

## Indications for use
In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection.

Source page: https://510kreport.com/device/K052457
Methodology: https://510kreport.com/methodology