510(k) · Cleared
ClearedCOMPACT INTUITIV Multiple-Use 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 Sep 2, 2015 as substantially equivalent to K133115 (Abbott Medical Optics, Inc., 2014) and 1 other predicate after a 63-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Sep 2, 2015
- Review
- 63 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K844373 (1985). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 3 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 2 generations backK111446 Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc. · 2011 · Recalled
- 1 generation backK133115 Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot…Abbott Medical Optics, Inc. · 2014 · Recalled
- This deviceK151783 COMPACT INTUITIV Multiple-Use PackAbbott Medical Optics, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −3 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −2 | K111446 | Sovereign Compact Phacoemulsification System | Abbott Medical Optics, Inc. | 2011 | 1 |
| −1 | K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal… | Abbott Medical Optics, Inc. | 2014 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…Summary page 4…t notification for the Multiple-Use Pack, Model OPO85, which is an accessory to the COMPACT INTUITIV Phacoemulsification System cleared under the premarket notification, K133115. This 510(k) Summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements of the Safe Me… | 2014 |
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 5…Sovereign Reusable Tubing Pack, Model OPO55 cleared on May 19, 1998, designed for use with the Sovereign Cataract Extraction Phacoemulsification System (K981116). COMPACT INTUITIV System and its components were shown to be substantially equivalent to the Sovereign Compact Phacoemulsificat… | 1998 |
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 30 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 8 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K133115.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 OPO85 is used with the COMPACT INTUITIV System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151783 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151783: COMPACT INTUITIV Multiple-Use Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151783
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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