Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rna Medical Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
103 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851362 | STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF | Rna Medical Corp. | 1985-06-12 | 69 | 0 |
| K844589 | OSMOLARITY STANDARDS | Rna Medical Corp. | 1985-03-01 | 95 | 0 |
| K842131 | FORMACLEAR- & MULTIPLE | Rna Medical Corp. | 1984-09-10 | 103 | 0 |
| K842519 | BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 | Rna Medical Corp. | 1984-08-17 | 38 | 0 |
| K830843 | BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- | Rna Medical Corp. | 1983-04-28 | 42 | 0 |
| K813447 | SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR | Rna Medical Corp. | 1981-12-31 | 30 | 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