Rna Medical Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Rna Medical Corp.” (first 1981, latest 1985), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| FKH | Solution-Test Standard-Conductivity, Dialysis | 1 | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JKT | Gas Chromatograph, Carbon-Monoxide | 1 | 1 |
| JMZ | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | 1 | 1 |
Review panels
Most recent Rna Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851362 | STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF | FKH | 1985-06-12 | 69 |
| K844589 | OSMOLARITY STANDARDS | JMZ | 1985-03-01 | 95 |
| K842131 | FORMACLEAR- & MULTIPLE | FKQ | 1984-09-10 | 103 |
| K842519 | BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 | CHL | 1984-08-17 | 38 |
| K830843 | BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- | JKT | 1983-04-28 | 42 |
| K813447 | SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR | JIS | 1981-12-31 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Rna Medical Corp..
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 Rna Medical Corp.?
FDA lists 6 510(k) clearances under the applicant name “Rna Medical Corp.” (first 1981, latest 1985), across 6 product codes in 3 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 Rna Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rna Medical Corp. is 56 days.
Which FDA product codes appear under Rna Medical Corp.?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 1); FKH (Solution-Test Standard-Conductivity, Dialysis, 1); FKQ (System, Dialysate Delivery, Central Multiple Patient, 1).
Next steps
- See all 6 Rna Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code CHL, Rna Medical Corp.'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.