R2 Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “R2 Corp.” (first 1980, latest 1983), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 3 | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
| IKD | Cable, Electrode | 1 | 1 |
| JOT | Electrode, Gel, Electrosurgical | 1 | 1 |
Review panels
Most recent R2 Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832516 | MAGNATRODE CARDIAC MONITORING ELECTRODE | DRX | 1983-12-16 | 141 |
| K800937 | R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 | LDD | 1980-05-23 | 32 |
| K800936 | R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 | LDD | 1980-05-23 | 32 |
| K800935 | R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) | DRX | 1980-05-23 | 32 |
| K800932 | ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 | DSA | 1980-05-23 | 32 |
| K800931 | R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 | DSA | 1980-05-23 | 32 |
| K800930 | R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. | DRX | 1980-05-23 | 32 |
| K800934 | R2 ESU CABLE-ADAPTER MODELS 160,161 | IKD | 1980-05-20 | 29 |
| K800933 | R2 ELECTROSURG. RETURN ELECT. #225ETC. | JOT | 1980-05-20 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named R2 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 R2 Corp.?
FDA lists 9 510(k) clearances under the applicant name “R2 Corp.” (first 1980, latest 1983), across 5 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 R2 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R2 Corp. is 32 days.
Which FDA product codes appear under R2 Corp.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 3); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 2); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 2).
Next steps
- See all 9 R2 Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRX, R2 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.