Stihler Electronic GmbH: FDA clearances and approvals
Stihler Electronic GmbH has 7 FDA 510(k) clearances (first 1999, latest 2026), across 4 product codes in 4 review panels. Median 510(k) review time: 148 days. openFDA lists 3 product recalls by a recalling firm named Stihler Electronic GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 160 |
Review time against the same product codes
Since 2017, Stihler Electronic GmbH's cleared 510(k)s took a median 95 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 2 | 2 |
| DWJ | System, Thermal Regulating | 2 | 2 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 2 |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 | 1 |
Review panels
Most recent Stihler Electronic GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260278 | ThermAffyx(TM) Patient Safety System | DWJ | 2026-07-08 | 160 |
| K202197 | Astopad Patient Warming System | DWJ | 2020-09-04 | 30 |
| K082758 | PRISMAFLO II | KOC | 2008-12-19 | 91 |
| K082765 | ASTOFLO PLUS | LGZ | 2008-12-18 | 87 |
| K020103 | PRISMAFLO | KOC | 2002-07-24 | 194 |
| K991159 | PRISMATHERM II, ASTOLINE | BSB | 1999-09-03 | 149 |
| K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | BSB | 1999-09-02 | 148 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-09-06.
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 Stihler Electronic GmbH have?
Stihler Electronic GmbH has 7 FDA 510(k) clearances (first 1999, latest 2026), across 4 product codes in 4 review panels.
How long does FDA take to clear Stihler Electronic GmbH's 510(k)s?
The median time from FDA receipt to decision across Stihler Electronic GmbH's cleared 510(k)s is 148 days.
What devices does Stihler Electronic GmbH make?
Its most frequent FDA product codes are BSB (Warmer, Blood, Non-Electromagnetic Radiation, 2); DWJ (System, Thermal Regulating, 2); KOC (Accessories, Blood Circuit, Hemodialysis, 2).
Has Stihler Electronic GmbH had device recalls?
openFDA lists 3 product recalls in 1 recall event by a recalling firm whose name matches Stihler Electronic GmbH; the most recent began 2018-09-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Stihler Electronic GmbH clearances with predicates and recalls
- Run predicate analysis for product code BSB, Stihler Electronic GmbH'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.