510(k) · Cleared
Clearedbioli lOL Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ast Products, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jun 4, 2020 as substantially equivalent to K182965 (Ast Products, Inc., 2019) after a 143-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jun 4, 2020
- Review
- 143 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001157 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK001157 Monarch II Iol Delivery SystemAlcon Research, Ltd. · 2000 · Recalled
- 2 generations backK063155 Monarch Iii Iol Delivery SystemAlcon Manufacturing, Ltd. · 2007 · Recalled
- 1 generation backK182965 BL-Cart IOL Delivery CartridgeAst Products, Inc. · 2019
- This deviceK200057 bioli lOL Delivery SystemAst Products, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001157 | Monarch II Iol Delivery System | Alcon Research, Ltd. | 2000 | 1 |
| −2 | K063155 | Monarch Iii Iol Delivery System | Alcon Manufacturing, Ltd. | 2007 | 1 |
| −1 | K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | 2019 | — |
| 0 (this device) | K200057 | bioli lOL Delivery System | Ast Products, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 MSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSS device
- #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K182965 | BL-Cart IOL Delivery CartridgeSummary page 4…n Name: Class I (21 CFR § 886.4300 Intraocular lens guide) Classification Panel: Ophthalmic (86) Product Code: MSS 6. Legally Marketed Predicates K182965 BL-Cart™ IOL Delivery Cartridge K200057… | 2019 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All MSS devicesMSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MSS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSS
54in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSS
429in 2025
MAUDE reports naming product code MSS, 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 | 2 | — | 0 | 445 |
| 2008 | 5 | 84 | 0 | 185 |
| 2009 | 5 | 197 | 0 | 186 |
| 2010 | 2 | — | 0 | 203 |
| 2011 | 2 | — | 0 | 95 |
| 2012 | 2 | — | 0 | 129 |
| 2013 | 5 | 141 | 0 | 203 |
| 2014 | 5 | 78 | 0 | 114 |
| 2015 | 3 | 156 | 0 | 127 |
| 2016 | 2 | — | 1 | 112 |
| 2017 | 3 | 30 | 1 | 114 |
| 2018 | 1 | — | 0 | 340 |
| 2019 | 3 | 67 | 0 | 271 |
| 2020 | 2 | — | 0 | 362 |
| 2021 | 1 | — | 0 | 289 |
| 2022 | 0 | — | 0 | 490 |
| 2023 | 3 | 54 | 0 | 330 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 1 | — | 0 | 429 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.
The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200057 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200057: bioli lOL Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200057
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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