510(k) · Cleared
ClearedAmo Phacoflex Inserter, Foldable Iol Insert Instr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan Medical Optics · KYB Lens, Guide, Intraocular
Cleared on Apr 7, 1994 after a 440-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 32 later devices descend from it.
- Decided
- Apr 7, 1994
- Review
- 440 days
- Class
- Class I
- Product code
- KYB
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- Descendant · cites it directly · 31 of its ownK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- Descendant · 2 generations on · 25 of its ownK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- Descendant · 3 generations on · 19 of its ownK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- Descendant · 4 generations on · 18 of its ownK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- Descendant · 5 generations on · 12 of its ownK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K961242Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996 · cites it directly31descendants
- K040837Multiject Injector and Microglide CartridgeMedicel AG · 2004 · 2 generations on25descendants
- K070669Iol Injector SetMedicel AG · 2007 · 3 generations on19descendants
- K092023Naviject SUB2-1P, Model: LP604430Medicel AG · 2009 · 4 generations on18descendants
- K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| +1 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| +2 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| +3 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| +4 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| +5 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961242 | Amo Phacoflex II Intersection System | 1996 | 31 |
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?
- Of its descendants, K961242 (Allergan, Inc., 1996) has gone furthest, with 31 descendants of its own.
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 | — |
https://510kreport.com/device/K930320 · printed Nov 3, 2026
Cite this page
510(k) Report. “K930320: Amo Phacoflex Inserter, Foldable Iol Insert Instr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930320
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026