510(k) · Cleared
ClearedLaminar Flow Phaco Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical Optics, Inc. · HQC Unit, Phacofragmentation
Cleared on Nov 7, 2011 as substantially equivalent to K951462 (Allergan Medical Optics, 1995) after a 129-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Nov 7, 2011
- Review
- 129 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951462 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951462 Amo Profinesse Iii Ultrasonic Handpiece SystemAllergan Medical Optics · 1995 · Recalled
- This deviceK111882 Laminar Flow Phaco TipsAbbott Medical Optics, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK121721 Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)Abbott Medical Optics, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK192418 Phacoemulsification Needle (Tip) and Irrigation SleeveRaico, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951462 | Amo Profinesse Iii Ultrasonic Handpiece System | Allergan Medical Optics | 1995 | 1 |
| 0 (this device) | K111882 | Laminar Flow Phaco Tips | Abbott Medical Optics, Inc. | 2011 | — |
| +1 | K121721 | Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable) | Abbott Medical Optics, Inc. | 2012 | 1 |
| +1 | K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 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 HQC? 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 HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 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 |
|---|---|---|---|
| * | K951462 | Amo Profinesse Iii Ultrasonic Handpiece SystemSummary page 1…n Dateili . AMO Profinesse Ill Phaco Tip AMO K951462 017799 Needle7 4.1 Device Description Phacoemuisification (Phaco) is a technique used during cata… | 1995 |
What descends from it? (2)
2 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?
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The Lamninar Flow Phacoemulsification Needles (Tips) are used to break up (emulsify)
the nucleus of a cataractous lens and remove the remaining nuclear fragments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111882: Laminar Flow Phaco Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111882
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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