Sauter AG: FDA clearances and approvals
Sauter AG has 5 FDA 510(k) clearances (first 2002, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time: 83 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 341 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLE | Sterilizer, Steam | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Sauter AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141879 | BELIMED STEAM STERILIZER MST-H | FLE | 2015-06-17 | 341 |
| K103841 | BELIMED STEAM STERILIZER MST-V | FLE | 2011-03-15 | 83 |
| K060337 | BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 | FLE | 2006-03-08 | 26 |
| K033538 | BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 | FLE | 2004-02-02 | 84 |
| K021223 | BELIMED STEAM STERILIZER, MODEL TOP 5000 | FLE | 2002-06-26 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Sauter AG.
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 Sauter AG have?
Sauter AG has 5 FDA 510(k) clearances (first 2002, latest 2015), across 1 product code in 1 review panel.
How long does FDA take to clear Sauter AG's 510(k)s?
The median time from FDA receipt to decision across Sauter AG's cleared 510(k)s is 83 days.
What devices does Sauter AG make?
Its most frequent FDA product codes are FLE (Sterilizer, Steam, 5).
Has Sauter AG had device recalls?
openFDA lists no recalls under a recalling firm name matching Sauter AG. Related entities may recall under other names.
Next steps
- See all 5 Sauter AG clearances with predicates and recalls
- Run predicate analysis for product code FLE, Sauter AG'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.