510(k) · Cleared
Recalled · Class II · 2022Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack
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 Feb 27, 2014 as substantially equivalent to K111446 (Abbott Medical Optics, Inc., 2011) and 1 other predicate after a 150-day review. Its family tree reaches back 3 generations to 1985. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2014
- Review
- 150 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K844373 (1985). 11 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 2 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 1 generation backK111446 Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc. · 2011 · Recalled
- This deviceK133115 Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot…Abbott Medical Optics, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK151636 AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR…Abbott Medical Optics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK203060 VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack…Johnson & Johnson Surgical Vision, Inc. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK151783 COMPACT INTUITIV Multiple-Use PackAbbott Medical Optics, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…Abbott Medical Optics, Inc. · 2015 · cites it directly1descendant
- K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…Johnson & Johnson Surgical Vision, Inc. · 2021 · 2 generations on0descendants
- K151783COMPACT INTUITIV Multiple-Use PackAbbott Medical Optics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −2 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −1 | K111446 | Sovereign Compact Phacoemulsification System | Abbott Medical Optics, Inc. | 2011 | 1 |
| 0 (this device) | K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal… | Abbott Medical Optics, Inc. | 2014 | — |
| +1 | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature… | Abbott Medical Optics, Inc. | 2015 | — |
| +2 | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and… | Johnson & Johnson Surgical Vision, Inc. | 2021 | 3 |
| +1 | K151783 | COMPACT INTUITIV Multiple-Use Pack | Abbott Medical Optics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K111446 | Sovereign Compact Phacoemulsification SystemSummary page 1…onsole and its components are substantially equivalent to the console and accessories of AMO's SOVEREIGN Compact Phacoemulsification System cleared on December 29, 2011 (K1 11446), and the fluidics pack is substantially equivalent to AMO's SOVEREIGN Compact Disposable Tubing Set cleared on May 19. 1998 (K98… | 2011 |
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 1…stem cleared on December 29, 2011 (K1 11446), and the fluidics pack is substantially equivalent to AMO's SOVEREIGN Compact Disposable Tubing Set cleared on May 19. 1998 (K981 116). Abbott Medical Optics Inc. 6-1 6… | 1998 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2022 | Class II | Z-1007-2023 | Process control | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K151636 (Abbott Medical Optics, Inc., 2015) has gone furthest, with 1 descendant 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. 2014, 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 COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133115: Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133115
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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