Columbia Scientific, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Columbia Scientific, Inc.” (first 1986, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 95 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| KGI | Densitometer, Bone | 1 | 1 |
Review panels
- Radiology (7)
Most recent Columbia Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011180 | CT/MASTER, VERSION 1.0 | JAK | 2001-06-27 | 71 |
| K924810 | SIM/PLANT | JAK | 1993-01-15 | 112 |
| K897000 | IMAGEMASTER-101(TM) | LLZ | 1990-03-23 | 95 |
| K885322 | 3D/DENTAL | JAK | 1989-02-09 | 43 |
| K880404 | CSI/QCT | KGI | 1988-11-17 | 293 |
| K870513 | CSI/3D | JAK | 1987-05-08 | 92 |
| K861852 | CSI/MPR OR CSI/MPR PLUS | LLZ | 1986-10-08 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Columbia Scientific, 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.
- Columbia Bioscience, Inc. (13 510(k)s)
- Columbia Medical & Surgical, Inc. (4 510(k)s)
- Columbia Diagnostics, Inc. (2 510(k)s)
- Columbia Laboratories, Inc. (1 510(k)s)
- Columbia Medical Manufacturing, LLC (1 510(k)s)
- Columbia Medical Mfg, LLC (1 510(k)s)
- Columbia Scientific Development, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Columbia Scientific, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Columbia Scientific, Inc.” (first 1986, latest 2001), 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 Columbia Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Columbia Scientific, Inc. is 95 days.
Which FDA product codes appear under Columbia Scientific, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 4); LLZ (System, Image Processing, Radiological, 2); KGI (Densitometer, Bone, 1).
Next steps
- See all 7 Columbia Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Columbia Scientific, 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.