510(k) · Cleared
ClearedPerfect Capsule
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milvella Pty., Ltd. · HQC Unit, Phacofragmentation
Cleared on Aug 20, 2003 as substantially equivalent to K874969 (Advanced Surgical Products, Inc., 1988) and 4 other predicates after a 146-day review. Its family tree reaches back 1 generation to 1984. 11 later devices descend from it.
- Decided
- Aug 20, 2003
- Review
- 146 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K842458 (1984). 5 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK842458 Site Simcoe Style I/a HandpieceChiron Vision Corp. · 1984
- This deviceK030957 Perfect CapsuleMilvella Pty., Ltd. · 2003
- Descendant · cites it directly · 9 of its ownK093210 Aqualase Capsule Wash TipAlcon Manufacturing, Ltd. · 2010
- Descendant · 2 generations on · 8 of its ownK112425 Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011
- Descendant · 3 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 3 of its ownK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK120912 Infiniti (R) Vision SystemAlcon Manufacturing, Ltd. · 2012 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K093210Aqualase Capsule Wash TipAlcon Manufacturing, Ltd. · 2010 · cites it directly9descendants
- K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011 · 2 generations on8descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 3 generations on6descendants
- K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017 · 4 generations on3descendants
- K120912Infiniti (R) Vision SystemAlcon Manufacturing, Ltd. · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842458 | Site Simcoe Style I/a Handpiece | Chiron Vision Corp. | 1984 | — |
| 0 (this device) | K030957 | Perfect Capsule | Milvella Pty., Ltd. | 2003 | — |
| +1 | K093210 | Aqualase Capsule Wash Tip | Alcon Manufacturing, Ltd. | 2010 | — |
| +2 | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | Alcon Manufacturing, Ltd. | 2011 | — |
| +3 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +4 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| +2 | K120912 | Infiniti (R) Vision System | Alcon Manufacturing, Ltd. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K874969 | Prisma Disposable Kratz Capsule PolisherSummary page 2…Class I, exempt Company: Advanced Surgical Products, Inc. Device : Prisma Disposable Capsule Polishers 51O(k): K874969, K874974, K874985 Company: Chiron Vision Corp. Device: Site Simcoe Style I/A Handpiece… | 1988 |
| * | K874974 | Prisma Disposable Simcoe Capsule PolisherSummary page 2…ss I, exempt Company: Advanced Surgical Products, Inc. Device : Prisma Disposable Capsule Polishers 51O(k): K874969, K874974, K874985 Company: Chiron Vision Corp. Device: Site Simcoe Style I/A Handpiece 51O(k):… | 1988 |
| * | K874985 | Prisma Disposable Capsule PolisherSummary page 2…mpt Company: Advanced Surgical Products, Inc. Device : Prisma Disposable Capsule Polishers 51O(k): K874969, K874974, K874985 Company: Chiron Vision Corp. Device: Site Simcoe Style I/A Handpiece 51O(k):… | 1988 |
| * | K842458 | Site Simcoe Style I/a HandpieceSummary page 2…: K874969, K874974, K874985 Company: Chiron Vision Corp. Device: Site Simcoe Style I/A Handpiece 51O(k): K842458 Company: Advanced Surgical Products, Inc. Device: Prisma Disposable Simcoe I/A Cannula… | 1984 |
| * | K874973 | Prisma Disposable Simcoe I/a CannulaSummary page 2…: K842458 Company: Advanced Surgical Products, Inc. Device: Prisma Disposable Simcoe I/A Cannula 51O(k): K874973 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS The intended use of the Perfect Capsule does not differ from… | 1988 |
| * | — | Ophthalmic Cannulas Named without a submission number |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 5 ancestors has a recall.
- Of its descendants, K093210 (Alcon Manufacturing, Ltd., 2010) has gone furthest, with 9 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 Milvella Perfect Capsule is intended for use after phacoemulsification of the natural crystalline lens for the purpose of removing residual cortex and/or epithelial cells, by providing a method for sealed capsule polishing and irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030957: Perfect Capsule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030957
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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