510(k) · Cleared
Recalled · Class II · 2016Disposable Microstaar Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Staar Sugical · KYB Lens, Guide, Intraocular
Cleared on Sep 19, 1994 after a 222-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 19, 1994
- Review
- 222 days
- Class
- Class I
- Product code
- KYB
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK940593 Disposable Microstaar InjectorStaar Sugical · 1994
- Descendant · cites it directly · 3 of its ownK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
- Descendant · cites it directly · 2 of its ownK101782 Microstaar Msi Injector System CartridgeStaar Japan · 2010
- Descendant · 2 generations on · 0 of its ownK172375 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017
- Descendant · 2 generations on · 0 of its ownK152357 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015
Most influential descendants
Showing 4 of 4 · See all- K090161Epiphany Injection SystemStaar Surgical Co. · 2009 · cites it directly3descendants
- K101782Microstaar Msi Injector System CartridgeStaar Japan · 2010 · cites it directly2descendants
- K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017 · 2 generations on0descendants
- K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940593 | Disposable Microstaar Injector | Staar Sugical | 1994 | — |
| +1 | K090161 | Epiphany Injection System | Staar Surgical Co. | 2009 | — |
| +1 | K101782 | Microstaar Msi Injector System Cartridge | Staar Japan | 2010 | — |
| +2 | K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2017 | — |
| +2 | K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 KYB? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2016 | Class II | Z-1964-2016 | Process control | The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090161 (Staar Surgical Co., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KYB devicesKYB Lens, Guide, Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KYB
161in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KYB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYB
389in 2025
MAUDE reports naming product code KYB, 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 | 3 | 161 | 0 | 570 |
| 2008 | 2 | — | 1 | 258 |
| 2009 | 0 | — | 1 | 73 |
| 2010 | 0 | — | 0 | 81 |
| 2011 | 0 | — | 0 | 58 |
| 2012 | 0 | — | 0 | 125 |
| 2013 | 0 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 1 | — | 0 | 160 |
| 2016 | 0 | — | 0 | 256 |
| 2017 | 0 | — | 0 | 335 |
| 2018 | 0 | — | 0 | 592 |
| 2019 | 0 | — | 0 | 703 |
| 2020 | 0 | — | 0 | 335 |
| 2021 | 0 | — | 0 | 349 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 0 | — | 1 | 393 |
| 2025 | 0 | — | 0 | 389 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K940593 · printed Nov 3, 2026
Cite this page
510(k) Report. “K940593: Disposable Microstaar Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K940593
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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