# Olympus America, Inc.

- Location (FDA's records): Melville, NY
- FDA decisions: 149 (1994–2012): 149 510(k) clearances
- Product codes: GCJ (10), EOQ (10), HET (8), ITX (8), OCZ (4), JIT (4), GEI (4), JIX (4), EOB (3), CFQ (3), FDS (3), MND (3)
- Predicates its devices cite: 88 (36 its own); citations of its devices by later devices: 203 (36 its own)
- Recalls linked to its devices: 71 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus Corp.: 28 (https://510kreport.com/company/olympus)
- Olympus Optical Co., Ltd.: 11 (https://510kreport.com/company/olympus-optical)
- Everest Medical Corp.: 3 (https://510kreport.com/company/everest-medical)
- Boehringer Mannheim Corp.: 3 (https://510kreport.com/company/boehringer-mannheim)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Aloka Co., Ltd.: 1 (https://510kreport.com/company/aloka)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)

## Firms that cite its devices most
- Olympus Optical Co., Ltd.: 38 (https://510kreport.com/company/olympus-optical)
- Olympus Medical Systems Corp.: 25 (https://510kreport.com/company/olympus-medical-systems)
- Olympus Winter & Ibe GmbH: 15 (https://510kreport.com/company/olympus-winter-ibe)
- Boston Scientific Corp: 8 (https://510kreport.com/company/boston-scientific)
- Horiba Abx: 7 (https://510kreport.com/company/horiba-abx)
- Beckman Coulter, Inc.: 6 (https://510kreport.com/company/beckman-coulter)
- Alfa Wassermann Diagnostic Technologies, Inc.: 5 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)
- Medicon Hellas S.A: 4 (https://510kreport.com/company/medicon-hellas-s-a)

## Its most-cited devices
- K954451: Evis 140 System (1996), cited by 10
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use (1998), cited by 8
- K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 (1999), cited by 7
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center (1996), cited by 7
- K961274: Olympus AU600 Clinical Chemistry Analyzer (1996), cited by 6
- K944610: Olympus Ultrasonic Probes (1995), cited by 6

## Recent decisions
- K111788: Endoeye HD II (Jan 13, 2012)
- K081615: Olympus Cea -  Carcinoembryonic Antigen (Mar 18, 2009)
- K073489: Olympus Iga Reagent (Feb 11, 2008)
- K073487: Olympus Igm Reagent (Feb 11, 2008)
- K073490: Olympus Igg Reagent (Feb 11, 2008)
- K062862: Olympus Uric Acid Reagent, Model OSR6X98 (Apr 6, 2007)
- K063804: Olympus Triglyceride Test System (Mar 23, 2007)
- K061499: Osferion (Jan 26, 2007)

Source page: https://510kreport.com/company/olympus-america