510(k) · Cleared
ClearedRE-Useable Microstaar Injector, Msi-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Staar Surgical Co. · KYB Lens, Guide, Intraocular
Cleared on Jun 10, 2004 as substantially equivalent to K861085 (Staar Surgical Co., 1986) after a 310-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jun 10, 2004
- Review
- 310 days
- Class
- Class I
- Product code
- KYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861085 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK861085 Elastic Lens Injector TMStaar Surgical Co. · 1986
- This deviceK032412 RE-Useable Microstaar Injector, Msi-SStaar Surgical Co. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861085 | Elastic Lens Injector TM | Staar Surgical Co. | 1986 | — |
| 0 (this device) | K032412 | RE-Useable Microstaar Injector, Msi-S | Staar Surgical Co. | 2004 | — |
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 |
|---|---|---|---|
| * | K861085 | Elastic Lens Injector TMSummary page 1…STAAR Surgical Company b. Device: MS 1-P Elastic Lens Injector c. 510(K): K861085 d. Date Cleared: 5/28/1986 4. A description of the device that is the subje… | 1986 |
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?
- Its one ancestor has no recall.
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 | — |
What is it indicated for?
The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to fold and insert STAAR Surgical 3 Piece Collamer Intraocular Lenses into the capsular bag or ciliary sulcus following cataract extraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032412: RE-Useable Microstaar Injector, Msi-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032412
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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