Controlrad, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Controlrad, Inc.” (first 2019, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 94 days, against 112 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2019 | 1 | 186 |
| 2020 | 3 | 103 |
| 2021 | 2 | 26 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Controlrad, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
- Radiology (5)
- General Hospital (1)
Most recent Controlrad, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213455 | ControlRad Select Model Z | OWB | 2021-11-24 | 29 |
| K211782 | ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 | OWB | 2021-07-01 | 22 |
| K202431 | ControlRad Select Model Z | OWB | 2020-12-23 | 120 |
| K200663 | ControlRad Trace Model 9 | OWB | 2020-06-24 | 103 |
| K200238 | ControlRad Sterile Cover | KKX | 2020-04-26 | 86 |
| K183109 | ControlRad Trace Model 8 | OWB | 2019-05-13 | 186 |
Recalls
openFDA lists no recalls under a recalling firm named Controlrad, 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 Controlrad, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Controlrad, Inc.” (first 2019, latest 2021), across 2 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 Controlrad, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Controlrad, Inc. is 94 days. Since 2017: 94 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Controlrad, Inc.?
The most frequent FDA product codes under this applicant name are OWB (Interventional Fluoroscopic X-Ray System, 5); KKX (Drape, Surgical, Antimicrobial, 1).
Next steps
- See all 6 Controlrad, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWB, Controlrad, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.