510(k) · Cleared
Clearedpioli IOL 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 Dec 15, 2017 as substantially equivalent to K142056 (Ast Products, Inc., 2015) after a 143-day review. Its family tree reaches back 8 generations to 1994. 5 later devices descend from it.
- Decided
- Dec 15, 2017
- Review
- 143 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930320 (1994). 13 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 7 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 6 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 5 generations backK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- 4 generations backK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
- 3 generations backK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- 2 generations backK103495 Asico Softip Injector SystemAsico, LLC · 2011
- 1 generation backK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- This deviceK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK181401 RxSight Insertion DeviceRxsight, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK192926 RxSight Insertion DeviceRxsight, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK231466 RxSight Insertion DeviceRxsight, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK231838 RxSight® Insertion Device (63002)Rxsight, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK261174 RxSight® Insertion DeviceRxsight, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K181401RxSight Insertion DeviceRxsight, Inc. · 2018 · cites it directly4descendants
- K192926RxSight Insertion DeviceRxsight, Inc. · 2020 · 2 generations on3descendants
- K231466RxSight Insertion DeviceRxsight, Inc. · 2023 · 3 generations on2descendants
- K231838RxSight® Insertion Device (63002)Rxsight, Inc. · 2023 · cites it directly1descendant
- K261174RxSight® Insertion DeviceRxsight, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −7 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −6 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −5 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| −4 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
| −3 | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| −2 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| −1 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
| 0 (this device) | K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017 | — |
| +1 | K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018 | — |
| +2 | K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020 | — |
| +3 | K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023 | — |
| +1 | K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023 | — |
| +2 | K261174 | RxSight® Insertion Device | Rxsight, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K142056 | Lioli Iol Delivery SystemSummary page 4…— Classification Name: Class | (21 CFR § 886.4300 Intraocular lens guide) — Classification Panel: Ophthalmic (86) — Product Code: MSS . Legally Marketed Predicates — K142056: lioli™ |OL Delivery System (Models: LIOLI-18, LIOLI-22, LIOLI-24) . Device Description The pioli™ IOL Delivery System is a sin… | 2015 |
What descends from it? (5)
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?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K181401 (Rxsight, Inc., 2018) has gone furthest, with 4 descendants of its own.
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. 2017, 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 pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens
(IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation
through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL
models validated for use with this device as indicated in the IOL approved labeling.
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/K172228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172228: pioli IOL Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172228
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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