Diamed Division Ill. Tool Works, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Diamed Division Ill. Tool Works, Inc.” (first 1978, latest 1986), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| KOD | Catheter, Urological | 4 | 4 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
Most recent Diamed Division Ill. Tool Works, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854953 | DIAMED MODELS 600, 900, 960, 964 | JAA | 1986-04-22 | 133 |
| K823450 | FEMALE EXTERNAL URINARY APPLIANCE | KNX | 1982-12-28 | 41 |
| K812281 | TOUCHLESS HOME-CATH | KOD | 1981-10-13 | 61 |
| K802665 | TOUCHLESS CLEAN-CATH | KOD | 1980-11-12 | 15 |
| K802664 | URINARY DRAINAGE UNT | KNX | 1980-11-12 | 15 |
| K790728 | TOUCHLESS TM FOLEY CATHETER KIT | KOD | 1979-06-01 | 49 |
| K760897 | STERILE URETHRAL CATHETER KIT | KOD | 1978-08-31 | 674 |
Recalls
openFDA lists no recalls under a recalling firm named Diamed Division Ill. Tool Works, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Diamed Division Ill. Tool Works, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Diamed Division Ill. Tool Works, Inc.” (first 1978, latest 1986), across 3 product codes in 2 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 Diamed Division Ill. Tool Works, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diamed Division Ill. Tool Works, Inc. is 49 days.
Which FDA product codes appear under Diamed Division Ill. Tool Works, Inc.?
The most frequent FDA product codes under this applicant name are KOD (Catheter, Urological, 4); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 2); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Next steps
- See all 7 Diamed Division Ill. Tool Works, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOD, Diamed Division Ill. Tool Works, 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.