510(k) · Cleared
ClearedAcrypak Folder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · KYB Lens, Guide, Intraocular
Cleared on Mar 31, 1997 as substantially equivalent to K913626 (Staar Surgical Co., 1991) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 31, 1997
- Review
- 97 days
- Class
- Class I
- Product code
- KYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903574 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK903574 Chiroflex Lens MicrosertChiron Ophthalmics · 1990
- This deviceK965185 Acrypak FolderAlcon Laboratories · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903574 | Chiroflex Lens Microsert | Chiron Ophthalmics | 1990 | — |
| 0 (this device) | K965185 | Acrypak Folder | Alcon Laboratories | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K913626 | Softrans InjectorSummary page 2…97 15 Alcon Laboratories, Inc. K965185 AcryPak® Folder 1. Predicate Devi The legally marketed device(s) to which we are claiming equivalence to is: 1. K913626, Softrans™ Injector, (STAAR Surgical Company) 2. K903574, ChiroFlex® Lens Microsert®, (Chiron Ophthalmics Inc.) 2. Device Descri… | 1991 |
| * | K903574 | Chiroflex Lens MicrosertSummary page 2…ryPak® Folder 1. Predicate Devi The legally marketed device(s) to which we are claiming equivalence to is: 1. K913626, Softrans™ Injector, (STAAR Surgical Company) 2. K903574, ChiroFlex® Lens Microsert®, (Chiron Ophthalmics Inc.) 2. Device Descrinti The AcryPak® Folder is a sterile, single-use IOL fol… | 1990 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K913626.
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 intended use of this device is to fold the Alcon ACRYSOF® intraocular lens prior to its insertion into the eye. The AcryPak® Folder is used as the folding forceps. A pair of implantation forceps is used to remove the folded lens from the AcryPak® Folder for lens implantation.
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/K965185 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965185: Acrypak Folder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965185
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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