Scican , Ltd.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Scican , Ltd.” (first 1991, latest 2022), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 112 days. Since 2017 the median was 147 days, against 165 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 |
|---|---|---|
| 2012 | 1 | 284 |
| 2013 | 0 | — |
| 2014 | 1 | 186 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 116 |
| 2018 | 0 | — |
| 2019 | 1 | 192 |
| 2020 | 1 | 248 |
| 2021 | 1 | 147 |
| 2022 | 1 | 94 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Scican , Ltd. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 165 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLE | Sterilizer, Steam | 13 | 13 |
| EFB | Handpiece, Air-Powered, Dental | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- General Hospital (14)
- Dental (7)
Most recent Scican , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K214057 | STATIM 6000B Vacuum Autoclave | FLE | 2022-03-31 | 94 |
| K210326 | Bravo G4 Chamber Autoclave | FLE | 2021-07-01 | 147 |
| K192910 | STATClave G4 Chamber Autoclave | FLE | 2020-06-19 | 248 |
| K190062 | STATCLAVE G4 Chamber Autoclave | FLE | 2019-07-26 | 192 |
| K172292 | SALUS - Hygiene Instrument Reprocessing Container | KCT | 2017-11-24 | 116 |
| K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | EGS | 2014-01-31 | 186 |
| K112872 | STATIM 2000 G4 CASSETTE | FLE | 2012-07-10 | 284 |
| K090937 | E-STATIS 40 SYSTEM | EBW | 2009-07-24 | 112 |
| K090265 | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V | FLE | 2009-05-15 | 101 |
| K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | EFB | 2008-02-04 | 70 |
11 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2023-06-22.
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 Scican , Ltd.?
FDA lists 21 510(k) clearances under the applicant name “Scican , Ltd.” (first 1991, latest 2022), across 7 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 Scican , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scican , Ltd. is 112 days. Since 2017: 147 days, versus 165 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Scican , Ltd.?
The most frequent FDA product codes under this applicant name are FLE (Sterilizer, Steam, 13); EFB (Handpiece, Air-Powered, Dental, 3); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 21 Scican , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLE, Scican , Ltd.'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.