Somas Medical Industries, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Somas Medical Industries, Inc.” (first 1984, latest 1986), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| DFI | Total Spinal-Fluid, Antigen, Antiserum, Control | 1 | 1 |
| JGQ | Turbidimetric, Total Protein | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (4)
- Immunology (1)
Most recent Somas Medical Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862179 | SOMAS LIQUID URINE CONTROL | JJY | 1986-07-01 | 22 |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | JGQ | 1984-07-06 | 37 |
| K840486 | TOTAL BILIRUBIN REAGENT | CIG | 1984-04-25 | 79 |
| K840974 | SOMAS HUMAN SPINAL FLUID CONTROL | DFI | 1984-04-05 | 30 |
| K840485 | TOTAL IRON UIBC/TIBC ASSAY | CFM | 1984-03-12 | 35 |
| K833787 | SOMAS CHLORIDE ASSAY KIT | — | 1984-01-11 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Somas Medical Industries, 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 Somas Medical Industries, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Somas Medical Industries, Inc.” (first 1984, latest 1986), across 6 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 Somas Medical Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Somas Medical Industries, Inc. is 36 days.
Which FDA product codes appear under Somas Medical Industries, Inc.?
The most frequent FDA product codes under this applicant name are CFM (Bathophenanthroline, Colorimetry, Iron (Non-Heme), 1); CIG (Diazo Colorimetry, Bilirubin, 1); DFI (Total Spinal-Fluid, Antigen, Antiserum, Control, 1).
Next steps
- See all 6 Somas Medical Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFM, Somas Medical Industries, 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.