Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sicat GmbH & Co. KG · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
283 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192348 | SICAT Implant V2.0 | Sicat GmbH & Co. KG | 2019-12-04 | 97 | 0 |
| K180262 | SICAT Endo | Sicat GmbH & Co. KG | 2018-03-12 | 41 | 0 |
| K153291 | SICAT OPTISLEEP | Sicat GmbH & Co. KG | 2016-03-31 | 139 | 0 |
| K143655 | SICAT OPTIMOTION | Sicat GmbH & Co. KG | 2015-10-02 | 283 | 0 |
| K133320 | SICAT FUNCTION | Sicat GmbH & Co. KG | 2014-02-25 | 120 | 0 |
| K103723 | SICAT IMPLANT V1.2 | Sicat GmbH & Co. KG | 2011-05-20 | 150 | 0 |
| K093090 | GALILEOS IMPLANT, VERSION 1.7 | Sicat GmbH & Co. KG | 2009-12-17 | 77 | 0 |
| K090119 | SICAT IMPLANT | Sicat GmbH & Co. KG | 2009-02-05 | 15 | 0 |
| K061472 | GALILEOS IMPLANT, V 1.0 | Sicat GmbH & Co. KG | 2006-06-09 | 10 | 0 |
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