510(k) · Cleared
ClearedAMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
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 19, 2015 as substantially equivalent to K111697 (Abbott Medical Optics, Inc., 2011) and 1 other predicate after a 124-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Oct 19, 2015
- Review
- 124 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K844373 (1985). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK151636 AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR…Abbott Medical Optics, Inc. · 2015
- 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 |
|---|---|---|---|---|---|
| −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) | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature… | Abbott Medical Optics, Inc. | 2015 | — |
| +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 |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K111697 | Amo Whitestar Signature Phacoemulsification SystemSummary page 4…ation System (“subject device”) is an updated version of its primary predicate device, the legally marketed AMO WHITESTAR Signature Phacoemulsification System cleared in K111697 on September 27, 2011. Like its primary predicate device, the subject device is designed for use by ophthalmologists in the surgi… | 2011 |
| * | K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…Summary page 5…ced Linear Foot Pedal (ALP) used with the subject device is substantially equivalent to the foot pedal used with the legally marketed COMPACT INTUITIV system, cleared in K133115. Legally marketed devices to which the submitter claims equivalence: 551100((kk)) C Clleeaarraannccee… | 2014 |
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)
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 13 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.
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 AMO WHITESTAR Signature Pro Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.
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/K151636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151636: AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151636
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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