# Toray Industries (America), Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 20 (1986–2004): 18 510(k) clearances and 2 original PMA approvals
- Product codes: KDI (5), FJI (4), DQX (3), FOZ (2), DWF (2), LPM (1), DSY (1), DQR (1), MAD (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Galt Medical Corp.: 1 (https://510kreport.com/company/galt-medical)
- Fresenius Medical Care North America: 1 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Renal Systems, Inc.: 1 (https://510kreport.com/company/renal-systems)

## Firms that cite its devices most
- Lake Region Medical: 1 (https://510kreport.com/company/lake-region-medical)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)

## Its most-cited devices
- K042370: Torayguide Guidewire (2004), cited by 2
- K002512: Toraysulfone Dialyzer (2001), cited by 1
- K935471: Filtryzer (TM) (1995), cited by 1

## Recent decisions
- K042370: Torayguide Guidewire (Dec 17, 2004)
- K030050: Toraysulfone Dialyzer, BS-L Series (Sep 29, 2003)
- K002512: Toraysulfone Dialyzer (Oct 15, 2001)
- K994198: Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0L (Aug 25, 2000)
- K942681: Filtryzer (Jun 22, 1995)
- K935471: Filtryzer (TM) (May 19, 1995)
- K940910: Filtryzer (May 4, 1995)
- P910054: Inoue Balloon Catheter (Jun 28, 1994)

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