510(k) · Cleared
ClearedUnit, Phacofragmentation
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 Jun 1, 2011 as substantially equivalent to K844373 (Optical Micro Systems, Inc., 1985) and 1 other predicate after a 232-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.
- Decided
- Jun 1, 2011
- Review
- 232 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K840695 (1984). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK840695 Phacoemulsification KitsInnovative Surgical Products, Inc. · 1984
- This deviceK103023 Unit, PhacofragmentationAbbott 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 · 2 generations on · 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 | K840695 | Phacoemulsification Kits | Innovative Surgical Products, Inc. | 1984 | — |
| 0 (this device) | 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 |
| +2 | 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 |
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? (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 |
|---|---|---|---|
| * | K844373 | O.M.S. Ultra-PhacoSummary page 1…Ophthalmic Devices Devices to Which Substantial Equivalence is Claimed: 510(k) Number Trade Name Manufacturer K844373 Ultra Phaco OMS* K840695 Phacoemulsification Kits Allergan [S… | 1985 |
| * | K840695 | Phacoemulsification KitsSummary page 1…nce is Claimed: 510(k) Number Trade Name Manufacturer K844373 Ultra Phaco OMS* K840695 Phacoemulsification Kits Allergan [SP* *AMO currently owns the rights to these devices. I)EV… | 1984 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121721 | Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable) | 2012 | 1 |
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103023: Unit, Phacofragmentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103023
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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