Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scican , Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
248 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K214057 | STATIM 6000B Vacuum Autoclave | Scican , Ltd. | 2022-03-31 | 94 | 0 |
| K210326 | Bravo G4 Chamber Autoclave | Scican , Ltd. | 2021-07-01 | 147 | 0 |
| K192910 | STATClave G4 Chamber Autoclave | Scican , Ltd. | 2020-06-19 | 248 | 1 |
| K190062 | STATCLAVE G4 Chamber Autoclave | Scican , Ltd. | 2019-07-26 | 192 | 1 |
| K172292 | SALUS - Hygiene Instrument Reprocessing Container | Scican , Ltd. | 2017-11-24 | 116 | 0 |
| K112872 | STATIM 2000 G4 CASSETTE | Scican , Ltd. | 2012-07-10 | 284 | 0 |
| K090937 | E-STATIS 40 SYSTEM | Scican , Ltd. | 2009-07-24 | 112 | 0 |
| K090265 | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V | Scican , Ltd. | 2009-05-15 | 101 | 0 |
| K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | Scican , Ltd. | 2008-02-04 | 70 | 0 |
| K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 | Scican , Ltd. | 2007-12-19 | 106 | 0 |
| K071891 | STATIS DENTAL HANDPIECES | Scican , Ltd. | 2007-09-13 | 66 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda