Denver Biomedical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Denver Biomedical, Inc.” (first 2001, latest 2005), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | 2 | 2 |
| KPM | Shunt, Peritoneal | 2 | 2 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | 1 | 1 |
Review panels
Most recent Denver Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | PNG | 2005-11-15 | 141 |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | DWM | 2005-10-06 | 30 |
| K012235 | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | KPM | 2001-10-04 | 79 |
| K011862 | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | KPM | 2001-07-12 | 28 |
| K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | DWM | 2001-06-28 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Denver Biomedical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Denver Biomedical, Inc. (a text match, not an official crosswalk):
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.
- Denver Biomedicals, Inc. (10 510(k)s)
- Denver Biomaterials, Inc. (4 510(k)s)
- Denver Splint Co. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Denver Biomedical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Denver Biomedical, Inc.” (first 2001, latest 2005), 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 Denver Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Denver Biomedical, Inc. is 30 days.
Which FDA product codes appear under Denver Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are DWM (Apparatus, Suction, Patient Care, 2); KPM (Shunt, Peritoneal, 2); PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling, 1).
Next steps
- See all 5 Denver Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWM, Denver Biomedical, 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.