510(k) · Cleared
ClearedReprocessed Phacoemulsification Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · NKX Needle, Phacoemulsification, Reprocessed
Cleared on Mar 19, 2007 as substantially equivalent to K955789 (Alcon Laboratories, 1996) after a 371-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Mar 19, 2007
- Review
- 371 days
- Class
- Class II
- Product code
- NKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831836 (1983). 5 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 | K831836 | Epsilon Ultrasonic Tip | CooperVision, Inc. | 1983 | — |
| −1 | K955789 | Alcon Series 20000 Legacy Mackool System | Alcon Laboratories | 1996 | — |
| 0 (this device) | K060648 | Reprocessed Phacoemulsification Tips | Alliance Medical Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 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 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 |
|---|---|---|---|
| * | K955789 | Alcon Series 20000 Legacy Mackool SystemSummary page 1…me: Needle, Phacoemulsification, Reprocessed Predicate Device 510(k) Title Manufacturer K955789 ALCON SERIES 20000 LEGACY Alcon Laboratories MACKOOL SYSTEM Device descr… | 1996 |
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 24 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K955789.
How does its category compare?
All NKX devicesNKX Needle, Phacoemulsification, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 as stated in the FDA summary.
https://510kreport.com/device/K060648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060648: Reprocessed Phacoemulsification Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060648
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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