# K192418: Phacoemulsification Needle (Tip) and Irrigation Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Raico, LLC
- Decided: May 27, 2020 after 266 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K840695 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121721: Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable), Abbott Medical Optics, Inc. (2012) Summary page 4.
- K111882: Laminar Flow Phaco Tips, Abbott Medical Optics, Inc. (2011) Summary page 4.

## Indications for use
The RAICO Phacoemulsification Tip is used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments. The RAICO Irrigation Sleeve is intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery. The RAICO Phacoemulsification Tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.

Source page: https://510kreport.com/device/K192418
Methodology: https://510kreport.com/methodology