510(k) · Cleared
Recalled · Class II · 2013Iol Injector Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicel AG · KYB Lens, Guide, Intraocular
Cleared on Nov 1, 2007 as substantially equivalent to K040837 (Medicel AG, 2004) after a 234-day review. Its family tree reaches back 3 generations to 1994. 19 later devices descend from it. It has been recalled once.
- Decided
- Nov 1, 2007
- Review
- 234 days
- Class
- Class I
- Product code
- KYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930320 (1994). 5 ancestors in all. 19 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 2 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 1 generation backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- This deviceK070669 Iol Injector SetMedicel AG · 2007
- Descendant · cites it directly · 18 of its ownK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- Descendant · 2 generations on · 12 of its ownK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- Descendant · 3 generations on · 9 of its ownK131958 Bausch & Lomb Injector SystemBausch & Lomb · 2014
- Descendant · 2 generations on · 7 of its ownK103495 Asico Softip Injector SystemAsico, LLC · 2011
- Descendant · 3 generations on · 6 of its ownK142056 Lioli Iol Delivery SystemAst Products, Inc. · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K092023Naviject SUB2-1P, Model: LP604430Medicel AG · 2009 · cites it directly18descendants
- K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012 · 2 generations on12descendants
- K131958Bausch & Lomb Injector SystemBausch & Lomb · 2014 · 3 generations on9descendants
- K103495Asico Softip Injector SystemAsico, LLC · 2011 · 2 generations on7descendants
- K142056Lioli Iol Delivery SystemAst Products, Inc. · 2015 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −2 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −1 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| 0 (this device) | K070669 | Iol Injector Set | Medicel AG | 2007 | — |
| +1 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| +2 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| +3 | K131958 | Bausch & Lomb Injector System | Bausch & Lomb | 2014 | — |
| +2 | K103495 | Asico Softip Injector System | Asico, LLC | 2011 | — |
| +3 | K142056 | Lioli Iol Delivery System | Ast Products, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K040837 | Multiject Injector and Microglide CartridgeSummary page 1…ntraocular lens guide. Classification Name: Folders and injectors, intraocular lens (1OL) (MSS, 886.4300) (3) Equivalent legally-marketed devices: K040837, Multiject injector, Medicel AG (4) Description The Medicel IOL Injector Set for intraocular lenses is intended… | 2004 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092023 | Naviject SUB2-1P, Model: LP604430 | 2009 | 18 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2013 | Class II | Z-1984-2013 | Use error | The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K092023 (Medicel AG, 2009) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K040837.
How does its category compare?
All KYB devicesKYB Lens, Guide, Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their 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/K070669 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070669: Iol Injector Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070669
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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