510(k) · Cleared
ClearedAsico Softip Injector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asico, LLC · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jun 29, 2011 as substantially equivalent to K040837 (Medicel AG, 2004) and 2 other predicates after a 212-day review. Its family tree reaches back 6 generations to 1994. 7 later devices descend from it.
- Decided
- Jun 29, 2011
- Review
- 212 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K930320 (1994). 11 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 5 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 4 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 3 generations backK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- 2 generations backK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
- 1 generation backK063802 Lenstec LC Injection SystemLenstec, Inc. · 2007
- This deviceK103495 Asico Softip Injector SystemAsico, LLC · 2011
- Descendant · cites it directly · 6 of its ownK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK172228 pioli IOL Delivery SystemAst Products, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK181401 RxSight Insertion DeviceRxsight, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK192926 RxSight Insertion DeviceRxsight, Inc. · 2020
- Descendant · 5 generations on · 2 of its ownK231466 RxSight Insertion DeviceRxsight, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142056Lioli Iol Delivery SystemAst Products, Inc. · 2015 · cites it directly6descendants
- K172228pioli IOL Delivery SystemAst Products, Inc. · 2017 · 2 generations on5descendants
- K181401RxSight Insertion DeviceRxsight, Inc. · 2018 · 3 generations on4descendants
- K192926RxSight Insertion DeviceRxsight, Inc. · 2020 · 4 generations on3descendants
- K231466RxSight Insertion DeviceRxsight, Inc. · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −5 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −4 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −3 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| −2 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
| −1 | K063802 | Lenstec LC Injection System | Lenstec, Inc. | 2007 | — |
| 0 (this device) | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| +1 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
| +2 | K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017 | — |
| +3 | K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018 | — |
| +4 | K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020 | — |
| +5 | K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K040837 | Multiject Injector and Microglide CartridgeSummary page 1…Reserve) 807.92(a)(3) Predicate Device(s) ____ ____ ___ ___ ___ Device K040837 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE K092023 NAVIJECT… | 2004 |
| * | K092023 | Naviject SUB2-1P, Model: LP604430Summary page 1…vice(s) ____ ____ ___ ___ ___ Device K040837 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE K092023 NAVIJECT SUB2-1P, MODEL: LP604430 K063802 LENSTEC LC INJECTI… | 2009 |
| * | K063802 | Lenstec LC Injection SystemSummary page 1…ice K040837 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE K092023 NAVIJECT SUB2-1P, MODEL: LP604430 K063802 LENSTEC LC INJECTION SYSTEM 807.92 (a)(4) Page 1 of 8… | 2007 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142056 | Lioli Iol Delivery System | 2015 | 6 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K142056 (Ast Products, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K040837.
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. 2011, 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 ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103495: Asico Softip Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103495
Report an extraction error
Are you the manufacturer?
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