Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diamed Division Ill. Tool Works, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
674 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854953 | DIAMED MODELS 600, 900, 960, 964 | Diamed Division Ill. Tool Works, Inc. | 1986-04-22 | 133 | 0 |
| K823450 | FEMALE EXTERNAL URINARY APPLIANCE | Diamed Division Ill. Tool Works, Inc. | 1982-12-28 | 41 | 0 |
| K812281 | TOUCHLESS HOME-CATH | Diamed Division Ill. Tool Works, Inc. | 1981-10-13 | 61 | 0 |
| K802665 | TOUCHLESS CLEAN-CATH | Diamed Division Ill. Tool Works, Inc. | 1980-11-12 | 15 | 0 |
| K802664 | URINARY DRAINAGE UNT | Diamed Division Ill. Tool Works, Inc. | 1980-11-12 | 15 | 0 |
| K790728 | TOUCHLESS TM FOLEY CATHETER KIT | Diamed Division Ill. Tool Works, Inc. | 1979-06-01 | 49 | 0 |
| K760897 | STERILE URETHRAL CATHETER KIT | Diamed Division Ill. Tool Works, Inc. | 1978-08-31 | 674 | 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