# K133115: Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Feb 27, 2014 after 150 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: 3 generations back to K844373 (1985). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111446: Sovereign Compact Phacoemulsification System, Abbott Medical Optics, Inc. (2011) Summary page 1.
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 1.

## Most influential descendants
- K151636: AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control (2015), 1 descendant of its own
- K203060: VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (2021), 0 descendants of its own
- K151783: COMPACT INTUITIV Multiple-Use Pack (2015), 0 descendants of its own

## Recalls of this device
- Dec 7, 2022 · Class II · Z-1007-2023: Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsif

## Indications for use
The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

Source page: https://510kreport.com/device/K133115
Methodology: https://510kreport.com/methodology