510(k) · Cleared
ClearedDignity Ophthalmic Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phacor Inc., A Santen Company · HQC Unit, Phacofragmentation
Cleared on May 22, 2003 as substantially equivalent to K981116 (Allergan, Inc., 1998) and 2 other predicates after a 17-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 22, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K953575 (1995). 17 ancestors in all, the oldest K831836 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK953575 Storz MVS-3201 Vitrectomy Probe PackStorz Instrument Co. · 1995
- 2 generations backK954816 Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic…Storz Instrument Co. · 1996
- 1 generation backK980488 Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 1998 · Recalled
- This deviceK031404 Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953575 | Storz MVS-3201 Vitrectomy Probe Pack | Storz Instrument Co. | 1995 | — |
| −2 | K954816 | Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior… | Storz Instrument Co. | 1996 | — |
| −1 | K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy System | Storz Instrument Co. | 1998 | 4 |
| 0 (this device) | K031404 | Dignity Ophthalmic Surgical System | Phacor Inc., A Santen Company | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 1…The Advanced Medical Optics device most closely equivalent to the Phacor Inc. device is the SovereignTM, cleared for commercial distribution under 51O(k) number K981116. The Alcon Laboratories device most closely equivalent to the Phacor Inc. device is the Legacy@ Series 20000TM,cleared for commer… | 1998 |
| * | K955789 | Alcon Series 20000 Legacy Mackool SystemSummary page 1…16. The Alcon Laboratories device most closely equivalent to the Phacor Inc. device is the Legacy@ Series 20000TM,cleared for commercial distribution under 510(k) number K955789. The Bausch & Lomb device most closely equivalent to the Phacor Inc. device is the MilleniurnTM, cleared for commercial distribut… | 1996 |
| * | K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy SystemSummary page 1…) number K955789. The Bausch & Lomb device most closely equivalent to the Phacor Inc. device is the MilleniurnTM, cleared for commercial distribution under 51O(k) number K980488. The significant differences between the DignityTh1Ophthalmic Surgical System and the three predicate devices, SovereignTM , Le… | 1998 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 17 ancestors have a recall of any class.
- 8 other devices also cite its predicate K981116.
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 Dignity™ Ophthalmic Surgical System is a Phacofragmentation device intended for use in cataract surgery to emulsify, and extract the cataract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031404: Dignity Ophthalmic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031404
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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