Sedecal., Sa.: FDA clearances and approvals
Sedecal., Sa. has 26 FDA 510(k) clearances (first 2002, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time: 36 days. Since 2017 its median was 54 days, against 50 days for all cleared 510(k)s in the same product codes. openFDA lists 53 product recalls by a recalling firm named Sedecal., Sa.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 83 |
| 2013 | 1 | 20 |
| 2014 | 2 | 82 |
| 2015 | 0 | — |
| 2016 | 1 | 54 |
| 2017 | 0 | — |
| 2018 | 1 | 101 |
| 2019 | 3 | 28 |
| 2020 | 1 | 55 |
| 2021 | 2 | 57 |
| 2022 | 2 | 40 |
| 2023 | 1 | 28 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sedecal., Sa.'s cleared 510(k)s took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 50 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 17 | 17 |
| KPR | System, X-Ray, Stationary | 6 | 6 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 3 | 3 |
Review panels
- Radiology (26)
Most recent Sedecal., Sa. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232185 | SM-IV | IZL | 2023-08-21 | 28 |
| K222951 | SM-V | IZL | 2022-11-21 | 55 |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | IZL | 2022-07-18 | 26 |
| K212291 | PHOENIX | IZL | 2021-09-14 | 54 |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | KPR | 2021-02-01 | 60 |
| K202293 | Radiographic System Challenge X | KPR | 2020-10-07 | 55 |
| K192936 | Soltus 500 | IZL | 2019-11-15 | 28 |
| K192011 | PhoeniX | IZL | 2019-09-25 | 58 |
| K191813 | MobileDiagnost wDR 2.2 | IZL | 2019-08-02 | 28 |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | IZL | 2018-01-26 | 101 |
16 earlier clearances. See the full list in Caduvo.
Recalls
53 product recalls in 7 recall events; 53 initiated in the last five years. Most recent: 2025-06-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sedecal., Sa. have?
Sedecal., Sa. has 26 FDA 510(k) clearances (first 2002, latest 2023), across 3 product codes in 1 review panel.
How long does FDA take to clear Sedecal., Sa.'s 510(k)s?
The median time from FDA receipt to decision across Sedecal., Sa.'s cleared 510(k)s is 36 days. Since 2017: 54 days, versus 50 days for all cleared 510(k)s in the same product codes.
What devices does Sedecal., Sa. make?
Its most frequent FDA product codes are IZL (System, X-Ray, Mobile, 17); KPR (System, X-Ray, Stationary, 6); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 3).
Has Sedecal., Sa. had device recalls?
openFDA lists 53 product recalls in 7 recall events by a recalling firm whose name matches Sedecal., Sa; the most recent began 2025-06-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Sedecal., Sa. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Sedecal., Sa.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.