# K050648: Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Optics, Inc.
- Decided: Apr 5, 2005 after 22 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: 2 generations back to K844373 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 1.
- K020734: Surge-Free Aspiration Adapter, Staar Surgical Co. (2002) Summary page 1.

## Indications for use
The SOVEREIGN® High Vacuum Pack is indicated for use with the SOVEREIGN' phacoemulsification machine. The SOVEREIGN' High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line. The SOVEREIGN' Compact High Vacuum Pack is indicated for use with the SOVEREIGN' Compact phacoemulsification machine. The SOVEREIGN" Compact High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.

Source page: https://510kreport.com/device/K050648
Methodology: https://510kreport.com/methodology