510(k) · Cleared
ClearedSovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Optics, Inc. · HQC Unit, Phacofragmentation
Cleared on Apr 5, 2005 as substantially equivalent to K981116 (Allergan, Inc., 1998) and 1 other predicate after a 22-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Apr 5, 2005
- Review
- 22 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K844373 (1985). 10 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −1 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| 0 (this device) | K050648 | Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack | Advanced Medical Optics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 1…valence is being claimed: Company: Advanced Medical Optics (AMO®) Device: SOVEREIGN® Phaco Pack 5 10(k): K981116 Date Cleared: May 19,1998 Company: Staar Surgical Company Device: Sta… | 1998 |
| * | K020734 | Surge-Free Aspiration AdapterSummary page 1…May 19,1998 Company: Staar Surgical Company Device: Staar Surge-free Aspiration Adapter 5 10(k): K020734 Date-Cleared: May 16, 2002 ADVANCED MEDICAL Optics, INC. ' SOVEREIGN HIGH VACUUM PACK 510(K)… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 8 other devices also cite its predicate K981116.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050648: Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050648
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026