# K121721: Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Oct 15, 2012 after 125 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K840695 (1984). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103023: Unit, Phacofragmentation, Abbott Medical Optics, Inc. (2011) Summary page 1.
- K111882: Laminar Flow Phaco Tips, Abbott Medical Optics, Inc. (2011) Summary page 1.

## Most influential descendants
- K192418: Phacoemulsification Needle (Tip) and Irrigation Sleeve (2020), 0 descendants of its own

## Recalls of this device
- Mar 14, 2024 · Class II · Z-1755-2024: Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially 

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

Source page: https://510kreport.com/device/K121721
Methodology: https://510kreport.com/methodology