Sicat GmbH & Co. KG: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sicat GmbH & Co. KG” (first 2006, latest 2019), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 97 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 | 0 | — |
| 2014 | 1 | 120 |
| 2015 | 1 | 283 |
| 2016 | 1 | 139 |
| 2017 | 0 | — |
| 2018 | 1 | 41 |
| 2019 | 1 | 97 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sicat GmbH & Co. KG took a median 69 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 7 | 7 |
| LRK | Device, Anti-Snoring | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
Most recent Sicat GmbH & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192348 | SICAT Implant V2.0 | LLZ | 2019-12-04 | 97 |
| K180262 | SICAT Endo | LLZ | 2018-03-12 | 41 |
| K153291 | SICAT OPTISLEEP | LRK | 2016-03-31 | 139 |
| K143655 | SICAT OPTIMOTION | MQC | 2015-10-02 | 283 |
| K133320 | SICAT FUNCTION | LLZ | 2014-02-25 | 120 |
| K103723 | SICAT IMPLANT V1.2 | LLZ | 2011-05-20 | 150 |
| K093090 | GALILEOS IMPLANT, VERSION 1.7 | LLZ | 2009-12-17 | 77 |
| K090119 | SICAT IMPLANT | LLZ | 2009-02-05 | 15 |
| K061472 | GALILEOS IMPLANT, V 1.0 | LLZ | 2006-06-09 | 10 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-07-15.
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 Sicat GmbH & Co. KG?
FDA lists 9 510(k) clearances under the applicant name “Sicat GmbH & Co. KG” (first 2006, latest 2019), across 3 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 Sicat GmbH & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sicat GmbH & Co. KG is 97 days.
Which FDA product codes appear under Sicat GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 7); LRK (Device, Anti-Snoring, 1); MQC (Mouthguard, Prescription, 1).
Next steps
- See all 9 Sicat GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Sicat GmbH & Co. KG'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.