# Ashitaka Factory of Terumo Corp.

- Location (FDA's records): Fujinomiya Shizuoka, JP
- FDA decisions: 6 (2013–2021): 6 510(k) clearances
- Names in FDA's records: Ashitaka Factory of Terumo Corp. (3); Ashitaka Factory of Terumo Corporation (3)
- Product codes: DQO (2), DQY (2), DQX (1), DTZ (1)
- 510(k) review time since 2016: median 133 days, against 117 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 8 (0 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
- Terumo Medical Corp.: 4 (https://510kreport.com/company/terumo-medical)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)

## Firms that cite its devices most
- Philips Medical System Nederland B.V.: 2 (https://510kreport.com/company/philips-medical-system-nederland)
- Embolx, Inc.: 1 (https://510kreport.com/company/embolx)
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)
- Biomerics Nle: 1 (https://510kreport.com/company/biomerics-nle)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Rapid Medical, Ltd.: 1 (https://510kreport.com/company/rapid-medical)
- Filmecc Co., Ltd.: 1 (https://510kreport.com/company/filmecc)

## Its most-cited devices
- K152740: Radifocus Glidewire (2015), cited by 5
- K150232: Radifocus Optitorque Angiographic Catheter (2015), cited by 1
- K170223: Progreat (2017), cited by 1
- K130520: Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2013), cited by 1

## Recent decisions
- K203521: FineCross M3 (Mar 3, 2021)
- K170223: Progreat (Jul 21, 2017)
- K161546: R2P SlenGuide (Oct 14, 2016)
- K152740: Radifocus Glidewire (Nov 16, 2015)
- K150232: Radifocus Optitorque Angiographic Catheter (Oct 19, 2015)
- K130520: Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (Mar 13, 2013)

Source page: https://510kreport.com/company/ashitaka-factory-of-terumo