510(k) · Cleared
ClearedOne Series Ultra Cartridge, Model 1VIPR30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Optics, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Oct 2, 2008 as substantially equivalent to K961242 (Allergan, Inc., 1996) and 1 other predicate after a 122-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Oct 2, 2008
- Review
- 122 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930320 (1994). 5 ancestors in all. 1 later device descends from it, 1 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 deviceK081545 One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK143434 One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesAbbott Medical Optics, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143434One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesAbbott Medical Optics, Inc. · 2015 · cites it directly0descendants
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) | K081545 | One Series Ultra Cartridge, Model 1VIPR30 | Advanced Medical Optics, Inc. | 2008 | — |
| +1 | K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 5…al equivalence is being claimed: Company: Advanced Medical Optics, Inc. (AMO®) Device: AMO® PhacoSertTM cartridge 510(k): K961242 Date Cleared: June 17, 1996 Company: IntraLuminal Therapeutics, Inc. Device: Safe-Cross… | 1996 |
| * | K031692 | Safe-Cross Deflecting Catheter, Model C114ND1Summary page 5…te Cleared: June 17, 1996 Company: IntraLuminal Therapeutics, Inc. Device: Safe-Cross® Deflecting Catheter 510(k): K031692 Date Cleared: August 22, 2003 Advanced Medical Optics, Inc., 1700 E. St. Andrew Place, Santa Ana, CA 92705 =… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | 2015 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K143434 (Abbott Medical Optics, Inc., 2015) has gone furthest, with 0 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. 2008, 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?
Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081545: One Series Ultra Cartridge, Model 1VIPR30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081545
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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