510(k) · Cleared
ClearedVit Commander System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scieran Technologies, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Nov 25, 1996 after a 206-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 25, 1996
- Review
- 206 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK961738 Vit Commander SystemScieran Technologies, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK980488 Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK031404 Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003
- Descendant · cites it directly · 0 of its ownK983797 D.O.R.C. Harmony Total Vitrectomy SystemDutch Ophthalmic USA, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See all- K980488Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 1998 · cites it directly1descendant
- K031404Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003 · 2 generations on0descendants
- K983797D.O.R.C. Harmony Total Vitrectomy SystemDutch Ophthalmic USA, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961738 | Vit Commander System | Scieran Technologies, Inc. | 1996 | — |
| +1 | K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy System | Storz Instrument Co. | 1998 | 4 |
| +2 | K031404 | Dignity Ophthalmic Surgical System | Phacor Inc., A Santen Company | 2003 | — |
| +1 | K983797 | D.O.R.C. Harmony Total Vitrectomy System | Dutch Ophthalmic USA, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K980488 (Storz Instrument Co., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K961738 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961738: Vit Commander System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961738
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026