Colorado Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Colorado Medical, Inc.” (first 1983, latest 1987), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| LIF | Dialyzer Reprocessing System | 4 | 4 |
| FIZ | Meter, Conductivity, Non-Remote | 1 | 1 |
| KXM | System Accessories, Extracorporeal | 1 | 1 |
Review panels
Most recent Colorado Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870689 | HR-3000 REUSE ADAPTOR | LIF | 1987-04-10 | 50 |
| K870471 | MODIFIED HR-3000 REUSE ADAPTOR | LIF | 1987-04-10 | 66 |
| K863471 | COLORADO MEDICAL MODEL PTC 1000 | KXM | 1986-10-02 | 23 |
| K853735 | COLORADO MEDICAL MODEL CTM-3000 | FIZ | 1985-10-04 | 28 |
| K841153 | ADAPTOR HR-3000 REUSE | LIF | 1984-07-16 | 119 |
| K830190 | AHR-3000 RE-USE ADAPTOR | LIF | 1983-05-27 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Colorado Medical, 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.
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.
- Colorado Medtech, Inc. (2 510(k)s)
- Colorado Therapeutics, LLC (2 510(k)s)
- Colorado Biomedical, Inc. (1 510(k)s)
- Colorado Catheter Company, Inc. (1 510(k)s)
- Colorado Hearing Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Colorado Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Colorado Medical, Inc.” (first 1983, latest 1987), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Colorado Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Colorado Medical, Inc. is 58 days.
Which FDA product codes appear under Colorado Medical, Inc.?
The most frequent FDA product codes under this applicant name are LIF (Dialyzer Reprocessing System, 4); FIZ (Meter, Conductivity, Non-Remote, 1); KXM (System Accessories, Extracorporeal, 1).
Next steps
- See all 6 Colorado Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIF, Colorado Medical, 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.