# K151783: COMPACT INTUITIV Multiple-Use Pack

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Sep 2, 2015 after 63 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: 4 generations back to K844373 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133115: Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack, Abbott Medical Optics, Inc. (2014) Summary page 4.
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 5.

## Indications for use
The OPO85 is used with the COMPACT INTUITIV System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

Source page: https://510kreport.com/device/K151783
Methodology: https://510kreport.com/methodology