510(k) · Cleared
Recalled · 2009Horizon Phacoemulsification System, Model HZN-2030
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Optisurgical, Inc. · HQC Unit, Phacofragmentation
Cleared on Jul 9, 2002 as substantially equivalent to K931354 (American Optical Corp., 1994) and 2 other predicates after a 140-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 9, 2002
- Review
- 140 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931354 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK931354 P4000 PhacoemulsifierAmerican Optical Corp. · 1994
- This deviceK020527 Horizon Phacoemulsification System, Model HZN-2030American Optisurgical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK080803 Visual Phacoemulsification System, Model 551American Optisurgical, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080803Visual Phacoemulsification System, Model 551American Optisurgical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931354 | P4000 Phacoemulsifier | American Optical Corp. | 1994 | — |
| 0 (this device) | K020527 | Horizon Phacoemulsification System, Model HZN-2030 | American Optisurgical, Inc. | 2002 | — |
| +1 | K080803 | Visual Phacoemulsification System, Model 551 | American Optisurgical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K931354 | P4000 PhacoemulsifierSummary page 1…ation Name: As per 2 1 CFR 886.4670, the product nomenclature is Phacofiagmentation System. Predicate P4000 Phacoemulsifier System (K93 1354) Devices Ocusystern Art Advantage (K.991852) OMS Diplomax Phacoemulsifier (K946054)… | 1994 |
| * | K991852 | Ocusystem Art Advantage, Model 995Summary page 1…Phacofiagmentation System. Predicate P4000 Phacoemulsifier System (K93 1354) Devices Ocusystern Art Advantage (K.991852) OMS Diplomax Phacoemulsifier (K946054) Intended Use The Horizon Phacoemulsification System p… | 1999 |
| * | K946054 | DiplomaxSummary page 1…P4000 Phacoemulsifier System (K93 1354) Devices Ocusystern Art Advantage (K.991852) OMS Diplomax Phacoemulsifier (K946054) Intended Use The Horizon Phacoemulsification System performs phacofragrnentatiod phacoemulsi… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080803 | Visual Phacoemulsification System, Model 551 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2009 | Not classified | Z-1808-2009 | Software change control | Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K080803 (American Optisurgical, Inc., 2008) has gone furthest, with 0 descendants of its own.
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 Horizon Phacoemulsification System performs
phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt
and extract cataractous lens material from the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020527 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020527: Horizon Phacoemulsification System, Model HZN-2030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020527
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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