510(k) · Cleared
ClearedRoyale AE 9036 LSP Injector
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 Nov 7, 2007 as substantially equivalent to K023737 (Anton Meyer & Co., Ltd., 2003) and 2 other predicates after a 13-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Nov 7, 2007
- Review
- 13 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K930320 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 backK023737 InjectorAnton Meyer & Co., Ltd. · 2003
- This deviceK073010 Royale AE 9036 LSP InjectorAsico, LLC · 2007
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 | K023737 | Injector | Anton Meyer & Co., Ltd. | 2003 | — |
| 0 (this device) | K073010 | Royale AE 9036 LSP Injector | Asico, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K023737 | InjectorSummary page 1…ular lens guide, Classification Number: CFR 886.4300 807.92(a)(3) Predicate Device(s) 10 (k) Number Device K 023737 Injector RoyaleW AE 9045 K 003768 MONARCH' II IOL Delivery System K 011392… | 2003 |
| * | K003768 | Monarch II Iol Delivery SystemSummary page 1…807.92(a)(3) Predicate Device(s) 10 (k) Number Device K 023737 Injector RoyaleW AE 9045 K 003768 MONARCH' II IOL Delivery System K 011392 Micra Instument Ltd. Lens Insertion System… | 2001 |
| * | K011392 | Micra Lens Injector, Micra Cartridge Lens, Micra Lens LoaderSummary page 1…vice(s) 10 (k) Number Device K 023737 Injector RoyaleW AE 9045 K 003768 MONARCH' II IOL Delivery System K 011392 Micra Instument Ltd. Lens Insertion System 807.92 (a)(4) Device Desc… | 2001 |
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 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
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. 2007, 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 Royalee AE-9036 LSP Injectors are reusable instruments to assist in Implanting Alcon ACRYSOF ® foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges D and Monarch II cartridge C for foldable intraocular lenses. The cartridges are loaded into the injector body. By pushing the piston, the lens-will be removed out of the cartridge and delivered to the desired position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073010: Royale AE 9036 LSP Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073010
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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