# K160236: Dual Pump Pack

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Apr 27, 2016 after 86 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 K911808 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060366: The Amo Ophthalmic Surgical System, Advanced Medical Optics, Inc. (2006) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Dec 7, 2022 · Class II · Z-1006-2023: 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 DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR SIGNATURE or WHITESTAR SIGNATURE PRO Systems (“WHITESTAR SIGNATURE System(s)”). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

Source page: https://510kreport.com/device/K160236
Methodology: https://510kreport.com/methodology