Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Somas Medical Industries, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
79 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862179 | SOMAS LIQUID URINE CONTROL | Somas Medical Industries, Inc. | 1986-07-01 | 22 | 0 |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Somas Medical Industries, Inc. | 1984-07-06 | 37 | 0 |
| K840486 | TOTAL BILIRUBIN REAGENT | Somas Medical Industries, Inc. | 1984-04-25 | 79 | 0 |
| K840974 | SOMAS HUMAN SPINAL FLUID CONTROL | Somas Medical Industries, Inc. | 1984-04-05 | 30 | 0 |
| K840485 | TOTAL IRON UIBC/TIBC ASSAY | Somas Medical Industries, Inc. | 1984-03-12 | 35 | 0 |
| K833787 | SOMAS CHLORIDE ASSAY KIT | Somas Medical Industries, Inc. | 1984-01-11 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda