# Tomey Corporation

- Location (FDA's records): Nagoya, JP
- FDA decisions: 6 (2002–2025): 6 510(k) clearances
- Names in FDA's records: Tomey Corporation (5); Tomey Corp. (1)
- Product codes: OBO (2), NQE (1), HKX (1), IYO (1), MXK (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Konan Medical, Inc.: 1 (https://510kreport.com/company/konan-medical)
- Canon, Inc.-Utsunomiya Optical Products Operation: 1 (https://510kreport.com/company/canon-utsunomiya-optical-products-operation)
- Storz Instrument Co.: 1 (https://510kreport.com/company/storz-instrument)
- Dgh Technology, Inc.: 1 (https://510kreport.com/company/dgh-technology)
- Optovue, Inc.: 1 (https://510kreport.com/company/optovue)
- Haag-Streit AG: 1 (https://510kreport.com/company/haag-streit)

## Its most-cited devices
- K213265: Tomey Cornea/Anterior Segment OCT CASIA2 (2022), cited by 1

## Recent decisions
- K252348: Tomey Optical Biometer OA-2000 (OA-2000) (Dec 18, 2025)
- K250553: Tomey Cornea/Anterior Segment OCT (CASIA2) (Jul 18, 2025)
- K213265: Tomey Cornea/Anterior Segment OCT CASIA2 (Apr 27, 2022)
- K171313: EM-4000 Specular Microscope (Jan 19, 2018)
- K073087: Non-Contact Tonometer, Model FT-1000 (Nov 18, 2008)
- K012803: AL-2000 Combined Biometer and Pachymeter (Apr 8, 2002)

Source page: https://510kreport.com/company/tomey