510(k) · Cleared
ClearedACCUJECT Injector Set 2.1-1P (LP604590)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicel AG · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Sep 16, 2025 as substantially equivalent to K113852 (Bausch & Lomb, Inc., 2012) after a 35-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Sep 16, 2025
- Review
- 35 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930320 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- 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 backK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- 2 generations backK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- 1 generation backK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- This deviceK252540 ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG · 2025
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 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| −2 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| −1 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| 0 (this device) | K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K113852 | Bausch & Lomb Iol InjectorSummary page 6…LP604590 Regulation: 21 CFR 886.4300 - Intraocular lens guide Product Code: MSS Predicate Device: B&L IOL injector System, INJ100 (K113852) Device Description: The ACCUJECT Injector Set is an assembled injection system that is single use w… | 2012 |
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 31 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 4 other devices also cite its predicate K113852.
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. 2025, 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 ACCUJECT IOL Injector is indicated to fold and insert BVI IOLs approved for use with this injector in the human eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252540: ACCUJECT Injector Set 2.1-1P (LP604590).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252540
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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