510(k) · Cleared
ClearedOne Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical Optics, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on May 6, 2015 as substantially equivalent to K081545 (Advanced Medical Optics, Inc., 2008) after a 156-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- May 6, 2015
- Review
- 156 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930320 (1994). 6 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 backK081545 One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc. · 2008
- This deviceK143434 One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesAbbott Medical Optics, Inc. · 2015
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 | K081545 | One Series Ultra Cartridge, Model 1VIPR30 | Advanced Medical Optics, Inc. | 2008 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K081545 | One Series Ultra Cartridge, Model 1VIPR30Summary page 5…tween the new 1VIPR30 and 1MTEC30 Cartridges and their predicate device, Cartridge Model 1VIRP30, which is manufactured by AMO and was cleared by FDA on October 2, 2008 (K081545), is the replacement of the biologically-derived internal coating material with a synthetic coating material. The coating will se… | 2008 |
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 21 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 6 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. 2015, 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?
Either the DK7786 or DK7791 handpiece is used in combination with the ONE SERIES Ultra Cartridge, Model 1VIPR30 to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.
The Model DK7796 handpiece is used in combination with the Model IMTEC30 cartridge to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143434: One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143434
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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