510(k) · Cleared
Recalled · Class II · 2024Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)
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 Oct 15, 2012 as substantially equivalent to K103023 (Abbott Medical Optics, Inc., 2011) and 1 other predicate after a 125-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 15, 2012
- Review
- 125 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K840695 (1984). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK840695 Phacoemulsification KitsInnovative Surgical Products, Inc. · 1984
- 1 generation backK103023 Unit, PhacofragmentationAbbott Medical Optics, Inc. · 2011
- This deviceK121721 Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)Abbott Medical Optics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK192418 Phacoemulsification Needle (Tip) and Irrigation SleeveRaico, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K192418Phacoemulsification Needle (Tip) and Irrigation SleeveRaico, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840695 | Phacoemulsification Kits | Innovative Surgical Products, Inc. | 1984 | — |
| −1 | K103023 | Unit, Phacofragmentation | Abbott Medical Optics, Inc. | 2011 | — |
| 0 (this device) | K121721 | Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable) | Abbott Medical Optics, Inc. | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K103023 | Unit, PhacofragmentationSummary page 1…below in Table 3-1: Table 3-1: Predicate Devices to which Substantial Equivalence is claimed AMO Iruigation Phaco Sleeve AAIO K103023 j05124/2011 Laminar Flow Priaco Tip AMO K111882 10/24/2011 Phato Tip Tab… | 2011 |
| * | K111882 | Laminar Flow Phaco TipsSummary page 1…s claimed AMO Iruigation Phaco Sleeve AAIO K103023 j05124/2011 Laminar Flow Priaco Tip AMO K111882 10/24/2011 Phato Tip Table 3-2 compares features of the proposed Phaco Tips to those of the predicate device, The L… | 2011 |
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 |
|---|---|---|---|
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2024 | Class II | Z-1755-2024 | Process control | Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 27.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K192418 (Raico, LLC, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Laminar Flow Phacoemulsification Tips are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.
The Irrigation Sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
The 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/K121721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121721: Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121721
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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