510(k) · Cleared
ClearedAssociate 2500 Dual and Compact Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dutch Ophthalmic Research Center International BV · HQC Unit, Phacofragmentation
Cleared on Jan 5, 2009 as substantially equivalent to K063331 (Bausch & Lomb, Inc., 2006) and 4 other predicates after a 187-day review. Its family tree reaches back 4 generations to 1985. 8 later devices descend from it.
- Decided
- Jan 5, 2009
- Review
- 187 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K844373 (1985). 16 ancestors in all. 8 later devices descend from it, 2 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 backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 1 generation backK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- This deviceK081877 Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009
- Descendant · cites it directly · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- Descendant · 2 generations on · 2 of its ownK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK212241 Quatera 700Carl Zeiss Meditec, AG · 2022
- Descendant · cites it directly · 1 of its ownK133562 Catarhex 3Oertli Instrumente AG · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · cites it directly5descendants
- K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · 2 generations on2descendants
- K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 2 generations on1descendant
- K212241Quatera 700Carl Zeiss Meditec, AG · 2022 · 2 generations on1descendant
- K133562Catarhex 3Oertli Instrumente AG · 2014 · cites it directly1descendant
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 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −1 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| 0 (this device) | K081877 | Associate 2500 Dual and Compact Systems | Dutch Ophthalmic Research Center International BV | 2009 | — |
| +1 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| +2 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | 1 |
| +2 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
| +2 | K212241 | Quatera 700 | Carl Zeiss Meditec, AG | 2022 | — |
| +1 | K133562 | Catarhex 3 | Oertli Instrumente AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K063331 | Bausch & Lomb NGX Microsurgical SystemSummary page 1…HQC, HQE) 3. PREDICATE DEVICES 510(k) Clearance Device Description Date_______________________ K063331 12/19/2006 Bausch & LombT m NGX Microsurgical System __________… | 2006 |
| * | K060366 | The Amo Ophthalmic Surgical SystemSummary page 1…2006 Bausch & LombT m NGX Microsurgical System ____________ (arktedas the Bausch & Lomb Stellaris) K060366 4/7/2006 - AMO Ophthalmic Surgical System (Mar… | 2006 |
| * | K021566 | Infiniti Our reading of the summary gave K021564, FDA’s number for Incompass Spinal Fixation System (Spinal Concepts, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Alcon Infiniti Cataract Extraction System”. | 2002 |
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 1…(Marketed as the AMO Signature) K02 1564 7/2/2002 Alcon InfinitiTM Cataract Extraction System K96 1310 6/27/1996 Storz Premiere II Microsurgical System… | 1996 |
| * | K952213 | Alcon Series 20000 Legacy PhacoemulsifierSummary page 1…(Marketed as the Bausch & LombTM Millennium Microsurgical System) K952213 8/9/1995 Alcon System 20000Tm Legacy® Microsurgical… | 1995 |
What descends from it? (8)
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)
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 24 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K142877 (Dutch Ophthalmic Research Center International BV, 2015) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K063331.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/aspiration, vitrectomy, illumination, air/fluid exchange and silicone oil injection & extraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081877: Associate 2500 Dual and Compact Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081877
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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