510(k) · Cleared
ClearedMentor Phacoemulsification Sistem Remote Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · HQC Unit, Phacofragmentation
Cleared on Feb 24, 1998 as substantially equivalent to K952213 (Alcon Laboratories, 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 24, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925828 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK925828 Modified Site TXR SystemsSite Microsurgical Systems, Inc. · 1994
- This deviceK974469 Mentor Phacoemulsification Sistem Remote ControlMentor Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925828 | Modified Site TXR Systems | Site Microsurgical Systems, Inc. | 1994 | — |
| 0 (this device) | K974469 | Mentor Phacoemulsification Sistem Remote Control | Mentor Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K952213 | Alcon Series 20000 Legacy PhacoemulsifierSummary page 2…controls. Please see the comparison table below. COMPARISON TABLE Feature Alcon Legacy Chiron Vision Mentor Remote Control | Catalyst Remote Phacoemulsification 510(k) K952213 | Control SIStem Remote Control 510(k) K925828 Wireless Infrared | YES YES YES, also may be hard- Remote Control wired Controls L… | 1995 |
| * | K925828 | Modified Site TXR SystemsSummary page 2…ow. COMPARISON TABLE Feature Alcon Legacy Chiron Vision Mentor Remote Control | Catalyst Remote Phacoemulsification 510(k) K952213 | Control SIStem Remote Control 510(k) K925828 Wireless Infrared | YES YES YES, also may be hard- Remote Control wired Controls LV. YES YES YES Pole Height Memory Access | YES… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K952213.
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 Mentor® Phacoemulsification SIStem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SIStem from a distance.
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/K974469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974469: Mentor Phacoemulsification Sistem Remote Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974469
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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