# K081877: Associate 2500 Dual and Compact Systems

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic Research Center International BV
- Decided: Jan 5, 2009 after 187 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844373 (1985). 16 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063331: Bausch & Lomb NGX Microsurgical System, Bausch & Lomb, Inc. (2006) Summary page 1.
- K060366: The Amo Ophthalmic Surgical System, Advanced Medical Optics, Inc. (2006) Summary page 1.
- K021566: Infiniti, Alcon Laboratories, Inc. (2002). 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”.
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 1.
- K952213: Alcon Series 20000 Legacy Phacoemulsifier, Alcon Laboratories (1995) Summary page 1.

## Most influential descendants
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own
- K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (2019), 2 descendants of its own
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- K212241: Quatera 700 (2022), 1 descendant of its own
- K133562: Catarhex 3 (2014), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K081877
Methodology: https://510kreport.com/methodology