510(k) · Cleared
Recalled · Class II · 2022Dual Pump 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 Apr 27, 2016 as substantially equivalent to K060366 (Advanced Medical Optics, Inc., 2006) after an 86-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 27, 2016
- Review
- 86 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911808 (1991). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK911808 Gemini Ophthalmic Surgery SystemAlcon Laboratories · 1991 · Recalled
- 1 generation backK060366 The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006 · Recalled
- This deviceK160236 Dual Pump PackAbbott Medical Optics, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK203060 VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack…Johnson & Johnson Surgical Vision, Inc. · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…Johnson & Johnson Surgical Vision, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911808 | Gemini Ophthalmic Surgery System | Alcon Laboratories | 1991 | 2 |
| −1 | K060366 | The Amo Ophthalmic Surgical System | Advanced Medical Optics, Inc. | 2006 | 1 |
| 0 (this device) | K160236 | Dual Pump Pack | Abbott Medical Optics, Inc. | 2016 | — |
| +1 | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and… | Johnson & Johnson Surgical Vision, Inc. | 2021 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K060366 | The Amo Ophthalmic Surgical SystemSummary page 4…m(s); WHITESTAR SIGNATURE PRO, WHITESTAR SIGNATURE and AMO Ophthalmic Surgical Phacoemulsification Systems cleared under the premarket notifications K151636, K111697 and K060366 respectively. This 510(k) Summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements o… | 2006 |
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 |
|---|---|---|---|
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced… | 2021 | 0 |
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-1006-2023 | 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 25 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K203060 (Johnson & Johnson Surgical Vision, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K060366.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR SIGNATURE or WHITESTAR SIGNATURE PRO Systems (“WHITESTAR SIGNATURE System(s)”). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.
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/K160236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160236: Dual Pump Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160236
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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