510(k) · Cleared
ClearedReprocessed Phacoemuisification Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical, Inc. · NKX Needle, Phacoemulsification, Reprocessed
Cleared on Sep 23, 2005 as substantially equivalent to K911808 (Alcon Laboratories, 1991) after a 206-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 23, 2005
- Review
- 206 days
- Class
- Class II
- Product code
- NKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911808 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK911808 Gemini Ophthalmic Surgery SystemAlcon Laboratories · 1991 · Recalled
- This deviceK050518 Reprocessed Phacoemuisification TipsAlliance Medical, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911808 | Gemini Ophthalmic Surgery System | Alcon Laboratories | 1991 | 2 |
| 0 (this device) | K050518 | Reprocessed Phacoemuisification Tips | Alliance Medical, Inc. | 2005 | — |
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 NKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 1…acoemulsification Tips Classification Name: Phacofragmentation System Predicate Device 510(k) Title Manufacturer K91 1808 Alcon® Series 20,000®1Legacy® Alcon®Surgical, Inc. Device description: Phacoemulsification Tips are used to emu… | 1991 |
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?
- Its one ancestor has a recall.
- 13 other devices also cite its predicate K911808.
How does its category compare?
All NKX devicesNKX Needle, Phacoemulsification, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKX
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NKX
Too few NKX 510(k)s in any year since 2007 to give a median.
Recalls per year · NKX
10in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKX
3in 2010
MAUDE reports naming product code NKX, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 10 | 3 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.
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/K050518 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050518: Reprocessed Phacoemuisification Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050518
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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