510(k) · Cleared
ClearedStorz Daisyplus Series Microsurgical Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Aug 11, 1989 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.
- Decided
- Aug 11, 1989
- Review
- 49 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 5 citing it directly.
- This deviceK894278 Storz Daisyplus Series Microsurgical SystemsStorz Instrument Co. · 1989
- Descendant · cites it directly · 49 of its ownK993154 Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · Recalled
- Descendant · 2 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 3 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- Descendant · 4 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- Descendant · 3 generations on · 13 of its ownK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K993154Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · cites it directly49descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 2 generations on47descendants
- K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 3 generations on30descendants
- K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 4 generations on19descendants
- K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894278 | Storz Daisyplus Series Microsurgical Systems | Storz Instrument Co. | 1989 | — |
| +1 | K993154 | Laser Photolysis System, Pharo Ophthalmic Surgery System | A.R.C. Laser Corp. | 2000 | 1 |
| +2 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +3 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| +4 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| +3 | K113479 | Optimedica Catalys Precision Laser System | Optimedica Corporation | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (56)
See all 565 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993154 | Laser Photolysis System, Pharo Ophthalmic Surgery System | 2000 | 49 |
| K962131 | Storz D4600 Air Exchange Line Pack | 1996 | 2 |
| K961831 | Storz DP5200 Irrigation Addministration Set Pack | 1996 | 1 |
| K961874 | Storz DP5100 Anterior Collection Cassette Pack | 1996 | 1 |
| K961820 | Storz DP4600 Anterior Intraocular Pressure Control Pack | 1996 | 0 |
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, K993154 (A.R.C. Laser Corp., 2000) has gone furthest, with 49 descendants 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/K894278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894278: Storz Daisyplus Series Microsurgical Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894278
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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