Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Toray Industries (America), Inc. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
433 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042370 | TORAYGUIDE GUIDEWIRE | Toray Industries (America), Inc. | 2004-12-17 | 108 | 0 |
| K030050 | TORAYSULFONE DIALYZER, BS-L SERIES | Toray Industries (America), Inc. | 2003-09-29 | 266 | 0 |
| K002512 | TORAYSULFONE DIALYZER | Toray Industries (America), Inc. | 2001-10-15 | 426 | 1 |
| K994198 | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L | Toray Industries (America), Inc. | 2000-08-25 | 256 | 0 |
| K942681 | FILTRYZER | Toray Industries (America), Inc. | 1995-06-22 | 380 | 0 |
| K935471 | FILTRYZER(TM) | Toray Industries (America), Inc. | 1995-05-19 | 550 | 2 |
| K940910 | FILTRYZER | Toray Industries (America), Inc. | 1995-05-04 | 433 | 1 |
| K884339 | TORAY FILTRYZER DIALYZERS | Toray Industries (America), Inc. | 1989-03-17 | 154 | 0 |
| K883407 | TORAY FILTRYZER BK SERIES | Toray Industries (America), Inc. | 1989-02-27 | 200 | 0 |
| K884083 | TORAY VASCULAR PROSTHESIS | Toray Industries (America), Inc. | 1989-01-12 | 107 | 0 |
| K882158 | MODIFIED TORAY FILTRYZER DIALYZERS | Toray Industries (America), Inc. | 1988-08-12 | 81 | 0 |
| K881236 | TORAY ANTHRON P-U CATHETERS | Toray Industries (America), Inc. | 1988-05-11 | 50 | 0 |
| K874542 | TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES | Toray Industries (America), Inc. | 1988-03-07 | 125 | 0 |
| K872983 | TORAY ANTHRON ANGIOGRAPHIC CATHETERS | Toray Industries (America), Inc. | 1987-11-20 | 112 | 0 |
| K872762 | TORAY ANTHRON AORTA BYPASS TUBES | Toray Industries (America), Inc. | 1987-09-24 | 73 | 0 |
| K861115 | TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE | Toray Industries (America), Inc. | 1986-07-11 | 108 | 0 |
| K861117 | ANTHRON CATHETERS & SETS | Toray Industries (America), Inc. | 1986-06-18 | 85 | 0 |
| K861116 | TORAY ANTHRON BYPASS TUBES | Toray Industries (America), Inc. | 1986-05-28 | 64 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda