Toray Industries (America), Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Toray Industries (America), Inc.” (first 1986, latest 2004), plus 2 PMA decisions, across 9 product codes in 4 review panels. Median 510(k) review time under this name: 118 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 5 | 5 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 4 | 4 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| DQR | Cannula, Catheter | 1 | 1 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| LPM | Lenses, Soft Contact, Extended Wear | 1 | 0 |
| MAD | Catheter, Percutaneous (Valvuloplasty) | 1 | 0 |
Review panels
Most recent Toray Industries (America), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042370 | TORAYGUIDE GUIDEWIRE | DQX | 2004-12-17 | 108 |
| K030050 | TORAYSULFONE DIALYZER, BS-L SERIES | KDI | 2003-09-29 | 266 |
| K002512 | TORAYSULFONE DIALYZER | KDI | 2001-10-15 | 426 |
| K994198 | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L | KDI | 2000-08-25 | 256 |
| K942681 | FILTRYZER | KDI | 1995-06-22 | 380 |
| K935471 | FILTRYZER(TM) | FJI | 1995-05-19 | 550 |
| K940910 | FILTRYZER | FJI | 1995-05-04 | 433 |
| K884339 | TORAY FILTRYZER DIALYZERS | FJI | 1989-03-17 | 154 |
| K883407 | TORAY FILTRYZER BK SERIES | KDI | 1989-02-27 | 200 |
| K884083 | TORAY VASCULAR PROSTHESIS | DSY | 1989-01-12 | 107 |
8 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P910054 | PMA | INOUE BALLOON CATHETER | 1994-06-28 |
| P840044 | PMA | TORAY SOFT CONTACT LENSES | 1986-01-24 |
Recalls
openFDA lists no recalls under a recalling firm named Toray Industries (America), Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Toray Industries (America), Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01997736: Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation (Completed, started 2013-11-22)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Toray Industries, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Toray Industries (America), Inc.?
FDA lists 18 510(k) clearances under the applicant name “Toray Industries (America), Inc.” (first 1986, latest 2004), plus 2 PMA decisions, across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Toray Industries (America), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Toray Industries (America), Inc. is 118 days.
Which FDA product codes appear under Toray Industries (America), Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 5); FJI (Dialyzer, Capillary, Hollow Fiber, 4); DQX (Wire, Guide, Catheter, 3).
Next steps
- See all 18 Toray Industries (America), Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Toray Industries (America), Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.