510(k) · Cleared
ClearedAlcon Series 20000 Legacy Mackool System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · HQC Unit, Phacofragmentation
Cleared on Mar 21, 1996 as substantially equivalent to K926512 (Storz, 1993) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Mar 21, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K831836 (1983). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK831836 Epsilon Ultrasonic TipCooperVision, Inc. · 1983
- This deviceK955789 Alcon Series 20000 Legacy Mackool SystemAlcon Laboratories · 1996
- Descendant · cites it directly · 0 of its ownK060648 Reprocessed Phacoemulsification TipsAlliance Medical Corp. · 2007
- Descendant · cites it directly · 0 of its ownK031404 Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831836 | Epsilon Ultrasonic Tip | CooperVision, Inc. | 1983 | — |
| 0 (this device) | K955789 | Alcon Series 20000 Legacy Mackool System | Alcon Laboratories | 1996 | — |
| +1 | K060648 | Reprocessed Phacoemulsification Tips | Alliance Medical Corp. | 2007 | — |
| +1 | K031404 | Dignity Ophthalmic Surgical System | Phacor Inc., A Santen Company | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K926512 | Storz Modified Phaco Needle with Insulation SleeveSummary page 2…e Phacofragmentation System (per 21 CFR 886.4670) 16 1. Predicate Device The currently marketed device(s) to which we are claiming equivalence are: a. K926512, Storz Modified Phaco Needle with Insulation Sleeve, (Storz Instrument Company) K 831836, Epsilon Ultrasonic Tips & Accessories… | 1993 |
| * | K831836 | Epsilon Ultrasonic TipSummary page 2…The currently marketed device(s) to which we are claiming equivalence are: a. K926512, Storz Modified Phaco Needle with Insulation Sleeve, (Storz Instrument Company) K 831836, Epsilon Ultrasonic Tips & Accessories, (CooperVision/Alcon Laboratories) c. Phacoemulsification tips associated with Alcon’s: K… | 1983 |
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 2…ve, (Storz Instrument Company) K 831836, Epsilon Ultrasonic Tips & Accessories, (CooperVision/Alcon Laboratories) c. Phacoemulsification tips associated with Alcon’s: K911808, Gemini Ophthalmic Surgery System (Senes 20,000° Legacy™) K861380, Series Ten Thousand Master 2. Device Description The Series… | 1991 |
| * | K861380 | Series Ten Thousand MasterSummary page 2…& Accessories, (CooperVision/Alcon Laboratories) c. Phacoemulsification tips associated with Alcon’s: K911808, Gemini Ophthalmic Surgery System (Senes 20,000° Legacy™) K861380, Series Ten Thousand Master 2. Device Description The Series 20000 Legacy System and its predicate devices use ultrasonic energ… | 1986 |
What descends from it? (2)
2 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?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K060648 (Alliance Medical Corp., 2007) 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 intended use of this device is the automated phacoemulsification of a cataractous natural crystalline lens.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955789: Alcon Series 20000 Legacy Mackool System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955789
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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