Denver Biomedicals, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Denver Biomedicals, Inc.” (first 1981, latest 2005), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| KPM | Shunt, Peritoneal | 6 | 6 |
| DWM | Apparatus, Suction, Patient Care | 2 | 2 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
Review panels
Most recent Denver Biomedicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | DWM | 2005-06-13 | 46 |
| K011020 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | KPM | 2001-06-01 | 58 |
| K010642 | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | DWM | 2001-03-20 | 15 |
| K003451 | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T | KPM | 2001-01-02 | 56 |
| K943968 | TUNNELER | MDM | 1995-03-01 | 198 |
| K913728 | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | KPM | 1994-02-18 | 913 |
| K842139 | THE DENVER PLEURAL-PERITONEAL SHUNT | KPM | 1984-08-27 | 89 |
| K822686 | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | KPM | 1982-09-21 | 18 |
| K811577 | CROUCH CORNEAL PROTECTOR | HOY | 1981-08-07 | 63 |
| K811183 | DENVER PERITONEO-VENOUS SHUNT | KPM | 1981-07-01 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Denver Biomedicals, 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 Biomedicals, 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 Biomedical, Inc. (5 510(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 Biomedicals, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Denver Biomedicals, Inc.” (first 1981, latest 2005), across 4 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 Denver Biomedicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Denver Biomedicals, Inc. is 60 days.
Which FDA product codes appear under Denver Biomedicals, Inc.?
The most frequent FDA product codes under this applicant name are KPM (Shunt, Peritoneal, 6); DWM (Apparatus, Suction, Patient Care, 2); HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), 1).
Next steps
- See all 10 Denver Biomedicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPM, Denver Biomedicals, 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.