Radi Medical Systems AB: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Radi Medical Systems AB” (first 1990, latest 2013), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 88 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 | 1 | 92 |
| 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | 8 | 8 |
| DQK | Computer, Diagnostic, Programmable | 4 | 4 |
| DXO | Transducer, Pressure, Catheter Tip | 4 | 4 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| DSK | Computer, Blood-Pressure | 2 | 2 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
Review panels
- Cardiovascular (21)
- General and Plastic Surgery (2)
- Radiology (1)
Most recent Radi Medical Systems AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123984 | QUANTIEN MEASUREMENT SYSTEM | DQK | 2013-03-28 | 92 |
| K092105 | RADIANALYZER XPRESS | DQK | 2009-10-09 | 87 |
| K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER | DXO | 2008-07-01 | 102 |
| K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | DXC | 2008-02-26 | 29 |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | DXO | 2006-12-04 | 80 |
| K042628 | MODIFICATION TO: RADIANALYZER, MODEL 12711 | DQK | 2005-01-19 | 114 |
| K033291 | TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 | QSY | 2004-03-17 | 155 |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | DXO | 2003-06-06 | 9 |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | DXC | 2002-12-24 | 11 |
| K022188 | RADIANALYZER, MODEL 12710 | DQK | 2002-10-03 | 90 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radi Medical Systems AB.
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 Radi Medical Systems AB?
FDA lists 24 510(k) clearances under the applicant name “Radi Medical Systems AB” (first 1990, latest 2013), across 8 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 Radi Medical Systems AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radi Medical Systems AB is 88 days.
Which FDA product codes appear under Radi Medical Systems AB?
The most frequent FDA product codes under this applicant name are DXC (Clamp, Vascular, 8); DQK (Computer, Diagnostic, Programmable, 4); DXO (Transducer, Pressure, Catheter Tip, 4).
Next steps
- See all 24 Radi Medical Systems AB clearances with predicates and recalls
- Run predicate analysis for product code DXC, Radi Medical Systems AB'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.