510(k) · Cleared
ClearedPhacoemulsification Needle (Tip) and Irrigation Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raico, LLC · HQC Unit, Phacofragmentation
Cleared on May 27, 2020 as substantially equivalent to K121721 (Abbott Medical Optics, Inc., 2012) and 1 other predicate after a 266-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- May 27, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K840695 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK840695 Phacoemulsification KitsInnovative Surgical Products, Inc. · 1984
- 2 generations backK103023 Unit, PhacofragmentationAbbott Medical Optics, Inc. · 2011
- 1 generation backK121721 Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)Abbott Medical Optics, Inc. · 2012 · Recalled
- This deviceK192418 Phacoemulsification Needle (Tip) and Irrigation SleeveRaico, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K840695 | Phacoemulsification Kits | Innovative Surgical Products, Inc. | 1984 | — |
| −2 | K103023 | Unit, Phacofragmentation | Abbott Medical Optics, Inc. | 2011 | — |
| −1 | K121721 | Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable) | Abbott Medical Optics, Inc. | 2012 | 1 |
| 0 (this device) | K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K121721 | Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)Summary page 4…mentation System (Product Code HQC; 21 CFR 886.4670) Classification: II 3. Predicate Devices 510(k) Number Device K121721 Laminar Flow Phacoemulsification Tip and Irrigation Sleeve (Primary Predicate) K111882… | 2012 |
| * | K111882 | Laminar Flow Phaco TipsSummary page 4…. Predicate Devices 510(k) Number Device K121721 Laminar Flow Phacoemulsification Tip and Irrigation Sleeve (Primary Predicate) K111882 Laminar Flow Phacoemulsification Tip Page 1 of 5… | 2011 |
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 36 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 RAICO Phacoemulsification Tip is used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.
The RAICO Irrigation Sleeve is intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
The RAICO Phacoemulsification Tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192418: Phacoemulsification Needle (Tip) and Irrigation Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192418
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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