510(k) · Cleared
ClearedMultiject Injector and Microglide Cartridge
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 Jun 17, 2004 as substantially equivalent to K961242 (Allergan, Inc., 1996) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1994. 25 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 78 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930320 (1994). 4 ancestors in all. 25 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 1 generation backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- This deviceK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- Descendant · cites it directly · 19 of its ownK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- Descendant · 3 generations on · 12 of its ownK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- Descendant · cites it directly · 12 of its ownK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK060533 Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K070669Iol Injector SetMedicel AG · 2007 · cites it directly19descendants
- K092023Naviject SUB2-1P, Model: LP604430Medicel AG · 2009 · 2 generations on18descendants
- K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012 · 3 generations on12descendants
- K050638Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular LensesLenstec, Inc. · 2005 · cites it directly12descendants
- K060533Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc. · 2006 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −1 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| 0 (this device) | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| +1 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| +2 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| +3 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| +1 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
| +1 | K060533 | Lenstec Intraocular Lens (Iol) Injection System | Lenstec, Inc. | 2006 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 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), 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? (2)
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 |
|---|---|---|---|
| * | K961242 | Amo Phacoflex II Intersection SystemSummary page 1…ens guide. Classification Name: Folders and injectors, intraocular lens (IOL) (MSS, 886.4300) (3) Equivalent legally-marketed devices: Allergan Phacoflex K961242 Alcon Monarch K003768 (4) Description The Medicel MultiJect injector for intraocular lenses is intended… | 1996 |
| * | K003768 | Monarch II Iol Delivery SystemSummary page 1…ion Name: Folders and injectors, intraocular lens (IOL) (MSS, 886.4300) (3) Equivalent legally-marketed devices: Allergan Phacoflex K961242 Alcon Monarch K003768 (4) Description The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocula… | 2001 |
What descends from it? (25)
See all 254 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070669 (Medicel AG, 2007) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K961242.
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.
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 Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040837: Multiject Injector and Microglide Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040837
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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