510(k) · Cleared
ClearedMicroSTAAR Injector System Cartridges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STAAR Surgical Company · KYB Lens, Guide, Intraocular
Cleared on Oct 30, 2015 as substantially equivalent to K101782 (Staar Japan, 2010) after a 71-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Oct 30, 2015
- Review
- 71 days
- Class
- Class I
- Product code
- KYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914311 (1992). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
- 4 generations backK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
- 3 generations backK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
- 2 generations backK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
- 1 generation backK101782 Microstaar Msi Injector System CartridgeStaar Japan · 2010
- This deviceK152357 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914311 | Chiroflex II Lens Microsert (TM) | Chiron Ophthalmics | 1992 | — |
| −4 | K970727 | Mport Foldable Lens Placement System | Chiron Vision Corp. | 1997 | 1 |
| −3 | K052651 | C-Flex System Single Use Disposable Injector, Model R-Inj-02 | Rayner Surgical, Inc. | 2006 | — |
| −2 | K090161 | Epiphany Injection System | Staar Surgical Co. | 2009 | — |
| −1 | K101782 | Microstaar Msi Injector System Cartridge | Staar Japan | 2010 | — |
| 0 (this device) | K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 2 | 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 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? (1)
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 |
|---|---|---|---|
| * | K101782 | Microstaar Msi Injector System CartridgeSummary page 4…Model: SFC 45 The primary device used for comparison in this summary is MicroSTAARO Injector System Cartridges(K101782). INTENDED USE The intended use of the MSI Cartridge in this submission is substantially equivalent to the… | 2010 |
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 23 years and passes through 6 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K101782.
How does its category compare?
All KYB devicesKYB Lens, Guide, Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.
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/K152357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152357: MicroSTAAR Injector System Cartridges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152357
Report an extraction error
Are you the manufacturer?
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