510(k) · Cleared
Recalled · 2008Reprocessed Phaco Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NKX Needle, Phacoemulsification, Reprocessed
Cleared on Nov 8, 2001 as substantially equivalent to K981103 (Alcon Laboratories, 1998) and 2 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1985. It has been recalled once.
- Decided
- Nov 8, 2001
- Review
- 91 days
- Class
- Class II
- Product code
- NKX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K851210 (1985). 11 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 | K851210 | United Sonics Phaco Module, DF-35 | United Sonics, Inc. | 1985 | — |
| −1 | K981103 | Turbosonics Limited Reuse Ultrasonic Tip | Alcon Laboratories | 1998 | — |
| 0 (this device) | K012579 | Reprocessed Phaco Tips | Sterilmed, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 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? (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 |
|---|---|---|---|
| * | K981103 | Turbosonics Limited Reuse Ultrasonic TipSummary page 5…umber: Class II, 21 CFR 886.4670 Product Code: HQC Predicate Dey'ice(s): The reprocessed phaco tip is substantially equivalent to: Alcon Limited Reuse Ultrasonic Tip (K981103), manufactured by Alcon; Phaco Tip (K914229), manufactured by Tri-Star Ophthalmic; Surgin High Efficiency Phaco Tip (K943102), ma… | 1998 |
| * | K914229 | Phaco TipSummary page 5…de: HQC Predicate Dey'ice(s): The reprocessed phaco tip is substantially equivalent to: Alcon Limited Reuse Ultrasonic Tip (K981103), manufactured by Alcon; Phaco Tip (K914229), manufactured by Tri-Star Ophthalmic; Surgin High Efficiency Phaco Tip (K943102), manufactured by Surgin; and the counterpart de… | 1991 |
| * | K943102 | High Performance TipsSummary page 5…ent to: Alcon Limited Reuse Ultrasonic Tip (K981103), manufactured by Alcon; Phaco Tip (K914229), manufactured by Tri-Star Ophthalmic; Surgin High Efficiency Phaco Tip (K943102), manufactured by Surgin; and the counterpart devices from the original manufacturer. The phaco tip is a component of the phacoe… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0565-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K981103.
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?
The intended use of this device is to assist in the automated phacoemulsification of a 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/K012579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012579: Reprocessed Phaco Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012579
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026