510(k) · Cleared
ClearedChiroflex Lens Microsert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Ophthalmics · KYB Lens, Guide, Intraocular
Cleared on Sep 17, 1990 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Sep 17, 1990
- Review
- 40 days
- Class
- Class I
- Product code
- KYB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903574 | Chiroflex Lens Microsert | Chiron Ophthalmics | 1990 | — |
| +1 | K970033 | Monarch Iol Delivery System | Alcon Laboratories | 1997 | — |
| +1 | K965185 | Acrypak Folder | Alcon Laboratories | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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? (2)
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, K970033 (Alcon Laboratories, 1997) has gone furthest, with 0 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/K903574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K903574: Chiroflex Lens Microsert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903574
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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